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← Vulvar Cancer

NCT03180294 · STUDY IN CONTEXT

Bupropion Hydrochloride in Improving Sexual Desire in Women With Breast or Gynecologic Cancer

Draft scope assessment: narrower. Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded. Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.

Read the full study record and all posted results →

Linked outcomes

Measures are not ranked. Open each original source section for treatment groups, denominators, units and results.

primary · POSTED

The desire subscore of the female sexual function index (FSFI) measures self-reported sexual desire. Possible scores range from 1.2 to 6, with higher scores indicating increased desire. Change score is calculated by subtracting baseline from later score, with a positive change score indicating increased desire. This measure is referred to as "sexual desire" in the protocol.

Eligible participants with baseline and 9 week data

→

secondary · POSTED

The PROMIS fatigue score measures self-reported fatigue symptoms over the past 7 days. Possible scores range from 33.1 to 77.8, with higher scores indicating more fatigue. Change score is calculated by subtracting baseline from later score, with a positive change score indicating increased fatigue.

Eligible with baseline data

→

secondary · POSTED

The desire subscore of the female sexual function index (FSFI) measures self-reported sexual desire. Possible scores range from 1.2 to 6, with higher scores indicating increased desire. Change score is calculated by subtracting baseline from later score, with a positive change score indicating increased desire. This measure is referred to as "sexual desire" in the protocol.

Eligible with baseline and 5 week data

→

secondary · POSTED

The PROMIS Global Satisfaction with Sex Life subscore measures self-reported global satisfaction, interest, and interference in sexual health over the past 7 days. Possible scores range from 3 to 30, with higher scores indicating more satisfaction with sex life. Change score is calculated by subtracting baseline from later score, with a positive change score indicating increased satisfaction. This score is referred to as the "PROMIS sexual desire and satisfaction measure" in the protocol.

Eligible with baseline data

→

secondary · POSTED

The FSFI total score measures self-reported female sexual functioning covering the major domains arousal, satisfaction, and orgasm, and including lubrication and pain. Possible scores range from 2 to 36, with higher scores indicating better functioning. Change score is calculated by subtracting baseline from later score, with a positive change score indicating increased functioning. This measure is referred to as "sexual functioning" in the protocol.

Eligible with baseline data

→

secondary · POSTED

The PHQ-4 is a brief screening questionnaire for depression. Possible scores range from 0 to 12, with higher scores indicating more severe depression. Change score is calculated by subtracting baseline from later score, with a negative change score indicating decreased severity of depression. This measure is referred to as "depressive mood" in the protocol.

Eligible with baseline data

→

Reported safety

Serious events are not the same as severe events. Compare the original safety groups and their at-risk populations.

Open the study safety table →

Quality of life and patient-reported measures

PROMIS · Change From Baseline in the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Score

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-vulvar-cancer
nct id
NCT03180294
qol key
qol-0001
source section id
NCT03180294-om-0001
source outcome index
1
instrument
PROMIS
instrument basis
matched 'promis' in the study's own wording
scale title
Change From Baseline in the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Score
measure definition
The PROMIS fatigue score measures self-reported fatigue symptoms over the past 7 days. Possible scores range from 33.1 to 77.8, with higher scores indicating more fatigue. Change score is calculated by subtracting baseline from later score, with a positive change score indicating increased fatigue.
time frame
Baseline (prior to randomization) and 5 and 9 weeks from start of study treatment (within 21 days of randomization)
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Eligible with baseline data
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
PROMIS · Change From Baseline in the PROMIS Global Satisfaction With Sex Life Subscore of Sexual Function and Satisfaction Measure ("Sexual Desire and Satisfaction")

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-vulvar-cancer
nct id
NCT03180294
qol key
qol-0003
source section id
NCT03180294-om-0003
source outcome index
3
instrument
PROMIS
instrument basis
matched 'promis' in the study's own wording
scale title
Change From Baseline in the PROMIS Global Satisfaction With Sex Life Subscore of Sexual Function and Satisfaction Measure ("Sexual Desire and Satisfaction")
measure definition
The PROMIS Global Satisfaction with Sex Life subscore measures self-reported global satisfaction, interest, and interference in sexual health over the past 7 days. Possible scores range from 3 to 30, with higher scores indicating more satisfaction with sex life. Change score is calculated by subtracting baseline from later score, with a positive change score indicating increased satisfaction. This score is referred to as the "PROMIS sexual desire and satisfaction measure" in the protocol.
time frame
Baseline (prior to randomization) and 5 and 9 weeks from start of study treatment (within 21 days of randomization)
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Eligible with baseline data
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
PRO-CTCAE · Number of Participants With Most Severe Response for Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) at 9 Weeks

Score direction: Not stated by the study. Direction is never inferred from an instrument name.

release id
clinical-indications-draft-1
disease state id
ds-vulvar-cancer
nct id
NCT03180294
qol key
qol-0009
source section id
NCT03180294-om-0009
source outcome index
9
instrument
PRO-CTCAE
instrument basis
matched 'pro-ctcae' in the study's own wording
scale title
Number of Participants With Most Severe Response for Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) at 9 Weeks
measure definition
Questions refer to the participants' experiences for the past 7 days of a given symptom in terms of frequency (never, rarely, occasionally, frequently, almost constantly), severity (none, mild, moderate, severe, very severe), interference with usual or daily activities (not at all, a little bit, somewhat, quite a bit, very much).
time frame
9 weeks from start of study treatment (within 21 days of randomization).
analysis role
secondary
reporting status
POSTED
higher is better
Source null
direction quote
Source null
population note
Eligible with 9 week data
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
Open the exact result →
Full draft applicability and source-link record
trial
release id
clinical-indications-draft-1
disease state id
ds-vulvar-cancer
nct id
NCT03180294
trial label
Bupropion Hydrochloride in Improving Sexual Desire in Women With Breast or Gynecologic Cancer
applicability
narrower
applicability note
Linked by condition-string match at the cancer-entity level. The study's eligibility - stage, biomarker, treatment line and prior therapy - has not been reconciled against this page's definition, so its population is narrower than this page in ways not yet recorded.
curation status
draft
reviewed by
Source null
reviewed at
Source null
created at
2026-09-10T00:00:00Z
provenance class
registry-condition-search
discovery note
Found by searching ClinicalTrials.gov for this cancer type, restricted to studies that have posted results to the registry. No FDA notice, FDA label or NCI summary held by this site cites this study. Because the search asked for posted results, studies without posted results were never looked for, so their absence from this page means nothing.
outcome Count
6
harms Count
3
qol Count
3
outcomes
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-vulvar-cancer
    nct id
    NCT03180294
    outcome key
    om-0000
    source section id
    NCT03180294-om-0000
    source outcome index
    0
    endpoint
    Change From Baseline at 9 Weeks in the Desire Subscore of the Female Sexual Function Index ("Sexual Desire")
    endpoint definition
    The desire subscore of the female sexual function index (FSFI) measures self-reported sexual desire. Possible scores range from 1.2 to 6, with higher scores indicating increased desire. Change score is calculated by subtracting baseline from later score, with a positive change score indicating increased desire. This measure is referred to as "sexual desire" in the protocol.
    time origin
    Baseline (prior to randomization) and 9 weeks from start of study treatment (within 21 days of randomization)
    analysis role
    primary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Eligible participants with baseline and 9 week data
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-vulvar-cancer
    nct id
    NCT03180294
    outcome key
    om-0001
    source section id
    NCT03180294-om-0001
    source outcome index
    1
    endpoint
    Change From Baseline in the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Score
    endpoint definition
    The PROMIS fatigue score measures self-reported fatigue symptoms over the past 7 days. Possible scores range from 33.1 to 77.8, with higher scores indicating more fatigue. Change score is calculated by subtracting baseline from later score, with a positive change score indicating increased fatigue.
    time origin
    Baseline (prior to randomization) and 5 and 9 weeks from start of study treatment (within 21 days of randomization)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Eligible with baseline data
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-vulvar-cancer
    nct id
    NCT03180294
    outcome key
    om-0002
    source section id
    NCT03180294-om-0002
    source outcome index
    2
    endpoint
    Change From Baseline at 5 Weeks in Desire Subscore of the FSFI ("Sexual Desire")
    endpoint definition
    The desire subscore of the female sexual function index (FSFI) measures self-reported sexual desire. Possible scores range from 1.2 to 6, with higher scores indicating increased desire. Change score is calculated by subtracting baseline from later score, with a positive change score indicating increased desire. This measure is referred to as "sexual desire" in the protocol.
    time origin
    Baseline (prior to randomization) and 5 weeks from start of study treatment (within 21 days of randomization)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Eligible with baseline and 5 week data
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-vulvar-cancer
    nct id
    NCT03180294
    outcome key
    om-0003
    source section id
    NCT03180294-om-0003
    source outcome index
    3
    endpoint
    Change From Baseline in the PROMIS Global Satisfaction With Sex Life Subscore of Sexual Function and Satisfaction Measure ("Sexual Desire and Satisfaction")
    endpoint definition
    The PROMIS Global Satisfaction with Sex Life subscore measures self-reported global satisfaction, interest, and interference in sexual health over the past 7 days. Possible scores range from 3 to 30, with higher scores indicating more satisfaction with sex life. Change score is calculated by subtracting baseline from later score, with a positive change score indicating increased satisfaction. This score is referred to as the "PROMIS sexual desire and satisfaction measure" in the protocol.
    time origin
    Baseline (prior to randomization) and 5 and 9 weeks from start of study treatment (within 21 days of randomization)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Eligible with baseline data
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-vulvar-cancer
    nct id
    NCT03180294
    outcome key
    om-0004
    source section id
    NCT03180294-om-0004
    source outcome index
    4
    endpoint
    Change From Baseline in FSFI Total Score ("Sexual Functioning")
    endpoint definition
    The FSFI total score measures self-reported female sexual functioning covering the major domains arousal, satisfaction, and orgasm, and including lubrication and pain. Possible scores range from 2 to 36, with higher scores indicating better functioning. Change score is calculated by subtracting baseline from later score, with a positive change score indicating increased functioning. This measure is referred to as "sexual functioning" in the protocol.
    time origin
    Baseline (prior to randomization) and 5 and 9 weeks from start of treatment (within 21 days of randomization)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Eligible with baseline data
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-vulvar-cancer
    nct id
    NCT03180294
    outcome key
    om-0005
    source section id
    NCT03180294-om-0005
    source outcome index
    5
    endpoint
    Change From Baseline in the Patient Health Questionnaire (PHQ)-4 Score ("Depressive Mood")
    endpoint definition
    The PHQ-4 is a brief screening questionnaire for depression. Possible scores range from 0 to 12, with higher scores indicating more severe depression. Change score is calculated by subtracting baseline from later score, with a negative change score indicating decreased severity of depression. This measure is referred to as "depressive mood" in the protocol.
    time origin
    Baseline (prior to randomization) and 5 and 9 weeks from start of treatment (within 21 days of randomization)
    analysis role
    secondary
    reporting status
    POSTED
    data cutoff
    Source null
    population note
    Eligible with baseline data
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
arms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-vulvar-cancer
    nct id
    NCT03180294
    outcome key
    om-0000
    arm key
    OG000
    arm label
    Bupropion 150 mg
    regimen
    One Bupropion 150 mg XL capsule by mouth (PO) in a.m. daily for one week; one Bupropion 150 mg XL capsule and one placebo capsule PO in a.m. daily for 8 weeks; one placebo capsule daily PO in a.m. for one 1 week (titration off).
    analyzed count
    66
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03180294-om-0000#groups/OG000
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-vulvar-cancer
    nct id
    NCT03180294
    outcome key
    om-0000
    arm key
    OG001
    arm label
    Bupropion 300 mg
    regimen
    One Bupropion 150 mg XL capsule PO in a.m. daily for one week; two Bupropion 150 mg XL capsules PO in a.m. daily for 8 weeks (300 mg target dose); one Bupropion 150 mg XL capsule PO in a.m. daily for 1 week (titration off)
    analyzed count
    59
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03180294-om-0000#groups/OG001
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-vulvar-cancer
    nct id
    NCT03180294
    outcome key
    om-0000
    arm key
    OG002
    arm label
    Placebo
    regimen
    One placebo capsule PO in a.m. daily for 1 week; two placebo capsules PO in a.m. daily for 8 weeks; one placebo capsule PO in a.m. daily for 1 week (titration off)
    analyzed count
    63
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03180294-om-0000#groups/OG002
  4. release id
    clinical-indications-draft-1
    disease state id
    ds-vulvar-cancer
    nct id
    NCT03180294
    outcome key
    om-0001
    arm key
    OG000
    arm label
    Bupropion 150 mg
    regimen
    One Bupropion 150 mg XL capsule PO in a.m. daily for one week; one Bupropion 150 mg XL capsule and one placebo capsule PO in a.m. daily for 8 weeks; one placebo capsule daily PO in a.m. for one 1 week (titration off).
    analyzed count
    79
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03180294-om-0001#groups/OG000
  5. release id
    clinical-indications-draft-1
    disease state id
    ds-vulvar-cancer
    nct id
    NCT03180294
    outcome key
    om-0001
    arm key
    OG001
    arm label
    Bupropion 300 mg
    regimen
    One Bupropion 150 mg XL capsule PO in a.m. daily for one week; two Bupropion 150 mg XL capsules PO in a.m. daily for 8 weeks (300 mg target dose); one Bupropion 150 mg XL capsule PO in a.m. daily for 1 week (titration off)
    analyzed count
    74
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03180294-om-0001#groups/OG001
  6. release id
    clinical-indications-draft-1
    disease state id
    ds-vulvar-cancer
    nct id
    NCT03180294
    outcome key
    om-0001
    arm key
    OG002
    arm label
    Placebo
    regimen
    One placebo capsule PO in a.m. daily for 1 week; two placebo capsules PO in a.m. daily for 8 weeks; one placebo capsule PO in a.m. daily for 1 week (titration off)
    analyzed count
    77
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03180294-om-0001#groups/OG002
  7. release id
    clinical-indications-draft-1
    disease state id
    ds-vulvar-cancer
    nct id
    NCT03180294
    outcome key
    om-0002
    arm key
    OG000
    arm label
    Bupropion 150 mg
    regimen
    One Bupropion 150 mg XL capsule PO in a.m. daily for one week; one Bupropion 150 mg XL capsule and one placebo capsule PO in a.m. daily for 8 weeks; one placebo capsule daily PO in a.m. for one 1 week (titration off).
    analyzed count
    66
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03180294-om-0002#groups/OG000
  8. release id
    clinical-indications-draft-1
    disease state id
    ds-vulvar-cancer
    nct id
    NCT03180294
    outcome key
    om-0002
    arm key
    OG001
    arm label
    Bupropion 300 mg
    regimen
    One Bupropion 150 mg XL capsule PO in a.m. daily for one week; two Bupropion 150 mg XL capsules PO in a.m. daily for 8 weeks (300 mg target dose); one Bupropion 150 mg XL capsule PO in a.m. daily for 1 week (titration off)
    analyzed count
    61
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03180294-om-0002#groups/OG001
  9. release id
    clinical-indications-draft-1
    disease state id
    ds-vulvar-cancer
    nct id
    NCT03180294
    outcome key
    om-0002
    arm key
    OG002
    arm label
    Placebo
    regimen
    One placebo capsule PO in a.m. daily for 1 week; two placebo capsules PO in a.m. daily for 8 weeks; one placebo capsule PO in a.m. daily for 1 week (titration off)
    analyzed count
    63
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03180294-om-0002#groups/OG002
  10. release id
    clinical-indications-draft-1
    disease state id
    ds-vulvar-cancer
    nct id
    NCT03180294
    outcome key
    om-0003
    arm key
    OG000
    arm label
    Bupropion 150 mg
    regimen
    One Bupropion 150 mg XL capsule PO in a.m. daily for one week; one Bupropion 150 mg XL capsule and one placebo capsule PO in a.m. daily for 8 weeks; one placebo capsule daily PO in a.m. for one 1 week (titration off).
    analyzed count
    79
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03180294-om-0003#groups/OG000
  11. release id
    clinical-indications-draft-1
    disease state id
    ds-vulvar-cancer
    nct id
    NCT03180294
    outcome key
    om-0003
    arm key
    OG001
    arm label
    Bupropion 300 mg
    regimen
    One Bupropion 150 mg XL capsule PO in a.m. daily for one week; two Bupropion 150 mg XL capsules PO in a.m. daily for 8 weeks (300 mg target dose); one Bupropion 150 mg XL capsule PO in a.m. daily for 1 week (titration off)
    analyzed count
    74
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03180294-om-0003#groups/OG001
  12. release id
    clinical-indications-draft-1
    disease state id
    ds-vulvar-cancer
    nct id
    NCT03180294
    outcome key
    om-0003
    arm key
    OG002
    arm label
    Placebo
    regimen
    One placebo capsule PO in a.m. daily for 1 week; two placebo capsules PO in a.m. daily for 8 weeks; one placebo capsule PO in a.m. daily for 1 week (titration off)
    analyzed count
    76
    analyzed unit
    Participants
    is comparator
    Source null
    source pointer
    NCT03180294-om-0003#groups/OG002
harms
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-vulvar-cancer
    nct id
    NCT03180294
    harm key
    EG000
    source section id
    NCT03180294-ae
    event group key
    EG000
    event group label
    Bupropion 150 mg
    serious affected
    1
    serious at risk
    77
    other affected
    53
    other at risk
    77
    frequency threshold
    5
    collection period
    1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).]
    event definition
    All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-vulvar-cancer
    nct id
    NCT03180294
    harm key
    EG001
    source section id
    NCT03180294-ae
    event group key
    EG001
    event group label
    Bupropion 300 mg
    serious affected
    0
    serious at risk
    73
    other affected
    55
    other at risk
    73
    frequency threshold
    5
    collection period
    1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).]
    event definition
    All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-vulvar-cancer
    nct id
    NCT03180294
    harm key
    EG002
    source section id
    NCT03180294-ae
    event group key
    EG002
    event group label
    Placebo
    serious affected
    0
    serious at risk
    76
    other affected
    57
    other at risk
    76
    frequency threshold
    5
    collection period
    1,2,5,7, and 9 weeks from start of study treatment (within 21 days of randomization).]
    event definition
    All-cause mortality was assessed in eligible participants. Adverse events were assessed in eligible participants with adverse event data who started protocol treatment.
    undenominated note
    Source null
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
quality of life
  1. release id
    clinical-indications-draft-1
    disease state id
    ds-vulvar-cancer
    nct id
    NCT03180294
    qol key
    qol-0001
    source section id
    NCT03180294-om-0001
    source outcome index
    1
    instrument
    PROMIS
    instrument basis
    matched 'promis' in the study's own wording
    scale title
    Change From Baseline in the Patient Reported Outcomes Measurement Information System (PROMIS) Fatigue Score
    measure definition
    The PROMIS fatigue score measures self-reported fatigue symptoms over the past 7 days. Possible scores range from 33.1 to 77.8, with higher scores indicating more fatigue. Change score is calculated by subtracting baseline from later score, with a positive change score indicating increased fatigue.
    time frame
    Baseline (prior to randomization) and 5 and 9 weeks from start of study treatment (within 21 days of randomization)
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Eligible with baseline data
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  2. release id
    clinical-indications-draft-1
    disease state id
    ds-vulvar-cancer
    nct id
    NCT03180294
    qol key
    qol-0003
    source section id
    NCT03180294-om-0003
    source outcome index
    3
    instrument
    PROMIS
    instrument basis
    matched 'promis' in the study's own wording
    scale title
    Change From Baseline in the PROMIS Global Satisfaction With Sex Life Subscore of Sexual Function and Satisfaction Measure ("Sexual Desire and Satisfaction")
    measure definition
    The PROMIS Global Satisfaction with Sex Life subscore measures self-reported global satisfaction, interest, and interference in sexual health over the past 7 days. Possible scores range from 3 to 30, with higher scores indicating more satisfaction with sex life. Change score is calculated by subtracting baseline from later score, with a positive change score indicating increased satisfaction. This score is referred to as the "PROMIS sexual desire and satisfaction measure" in the protocol.
    time frame
    Baseline (prior to randomization) and 5 and 9 weeks from start of study treatment (within 21 days of randomization)
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Eligible with baseline data
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
  3. release id
    clinical-indications-draft-1
    disease state id
    ds-vulvar-cancer
    nct id
    NCT03180294
    qol key
    qol-0009
    source section id
    NCT03180294-om-0009
    source outcome index
    9
    instrument
    PRO-CTCAE
    instrument basis
    matched 'pro-ctcae' in the study's own wording
    scale title
    Number of Participants With Most Severe Response for Patient-Reported Outcomes Version of the Common Terminology Criteria for Adverse Events (PRO-CTCAE) at 9 Weeks
    measure definition
    Questions refer to the participants' experiences for the past 7 days of a given symptom in terms of frequency (never, rarely, occasionally, frequently, almost constantly), severity (none, mild, moderate, severe, very severe), interference with usual or daily activities (not at all, a little bit, somewhat, quite a bit, very much).
    time frame
    9 weeks from start of study treatment (within 21 days of randomization).
    analysis role
    secondary
    reporting status
    POSTED
    higher is better
    Source null
    direction quote
    Source null
    population note
    Eligible with 9 week data
    curation status
    draft
    reviewed by
    Source null
    reviewed at
    Source null
    created at
    2026-09-10T00:00:00Z
setting source links

    Preserved source evidence · Not medical advice