NCT00698035 · REGISTRY CONDITION SEARCH

Vaginal Testosterone Cream vs ESTRING for Vaginal Dryness or Decreased Libido in Early Stage Breast Cancer Patients

Found through the registry condition index, not selected as a treatment recommendation. This discovery collection was restricted to studies with posted results.

Phase: PHASE2
Status at capture: COMPLETED
Registry last update: 2014-06-02

The purpose of this clinical research study is to determine whether the ESTRING or a special preparation of a testosterone cream inserted vaginally are safe for use in breast cancer patients. This study will also evaluate if either of these treatments can improve symptoms of vaginal dryness or decreased sexual interest that are related to your treatment for breast cancer.

Open the original ClinicalTrials.gov record → · Download preserved record

What did the study report?

Outcomes, safety and baseline populations are separate source sections. Quality-of-life measures appear under their original outcome titles.

flow

Participant flow

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baseline

Baseline characteristics

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outcome · POSTED

Serum Estradiol (E2)

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outcome · POSTED

Matched E2 by Commercial and Research (RIA) Analyses

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outcome · POSTED

Persistently Elevated Serum Estradiol Level Outside the Post-menopausal Range

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outcome · POSTED

Total Testosterone Levels

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outcome · POSTED

Sexual Quality of Life

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outcome · POSTED

Sexual Satisfaction

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outcome · POSTED

Change in Vaginal Epithelium Scores

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adverse events

Adverse events

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more info

Limitations, agreements, and source contact

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Who could take part

eligibility Criteria: Inclusion Criteria: 1. Histologically or cytologically confirmed Stage I-III breast cancer who are taking an aromatase inhibitor as adjuvant hormonal therapy. Patient must have started the aromatase inhibitor at least 60 days prior to enrolling. 2. Postmenopausal estradiol levels at baseline as measured by standard laboratory analysis. * Patient may be rendered postmenopausal through the use of a GnRH agonist, but must have confirmed post-menopausal levels of serum estradiol on two lab tests at least one month apart. * If patient has been rendered post-menopausal by adjuvant chemotherapy but has had a period within the past 12 months, post-menopausal levels of serum estradiol must be documented on two lab tests at least 3 months apart. 3. Age ≥18 and ≤80 years old. 4. ECOG ≤1 5. Adequate hematologic, hepatic, and renal function as defined by: * Hgb ≥9 g/dL * Absolute neutrophil count (ANC)/absolute granulocyte count (AGC) ≥1500 cells/mm3 * Platelet count ≥100,000/mm3 * Serum creatinine ≤1.5 mg/dL * Total bilirubin ≤1.5 times the ULN; and aspartate aminotransferase ≤3 times the ULN 6. Normal thyroid function tested within the past 6 months (Patients with a diagnosis of hypothyroidism and on thyroid supplementation must have had thyroid function tests in the normal range within the past 3 months) 7. Patient must have recovered from the side effects of previous chemotherapy, surgery, or radiation therapy for early breast cancer. Exclusion Criteria: 1. History of radiation to the vaginal area 2. Concurrent treatment with any type of oral, injectable or topical form of estrogen or androgen therapy including natural supplements marketed as hormone replacement products 3. Initiation of topical moisturizers (for example, Replens), or herbal or alternative medicines to manage the symptoms of vaginal dryness while on study. Patients who were previously using these products may continue them with the same usage pattern while on study. 4. Use of vaginal hormonal products (rings, inserts, creams, gels) containing estrogens or androgens within the past 30 days. 5. History of an abnormal pap smear within the last 12 months 6. History of endometrial or ovarian cancer 7. Any episode of vaginal bleeding in the past 6 months that has not been evaluated by a gynecological exam and/or pelvic ultrasound 8. History of sexual dysfunction prior to diagnosis of breast cancer ( Sexual dysfunction will be defined as loss of libido or inability to achieve orgasm for which patient sought medical attention or which patient felt significantly interfered with quality of life.) 9. Moderate or severe depression for which the patient is receiving ongoing psychological counseling and/or taking antidepressants, and for whom, in the investigators opinion may be interfering in the patients sexual function independent of the side effects of breast cancer and aromatase inhibitor use. 10. Use of any investigational agent for breast cancer within 3 weeks of study entry.
healthy Volunteers: false
maximum Age: 80 Years
minimum Age: 18 Years
sex: FEMALE
std Ages: ADULT
OLDER_ADULT

Treatment arms and interventions

arm Groups

description
Testosterone Cream 1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment
intervention Names
Drug: Testosterone Cream
label
Testosterone Cream
type
ACTIVE_COMPARATOR
description
Estring 2mg ring inserted vaginally once every 12 weeks
intervention Names
Drug: Estring
label
Estring
type
ACTIVE_COMPARATOR

interventions

arm Group Labels
Testosterone Cream
description
1% micronized in velvachol - 0.5 gm of cream vaginally each night for two weeks, then 3 times a week for total of 12 weeks of treatment
name
Testosterone Cream
other Names
intravaginal testosterone cream
type
DRUG
arm Group Labels
Estring
description
2mg ring inserted vaginally once every 12 weeks
name
Estring
other Names
ESTRING Estrodial Vaginal Ring
type
DRUG

Study design

allocation

RANDOMIZED

intervention Model

PARALLEL

masking Info

masking: NONE

primary Purpose

SUPPORTIVE_CARE

Enrollment

count: 76
type: ACTUAL

Registered outcome plans (not posted results)

primary Outcomes

description
Liquid chromatography tandem mass spectrometry (Quest Diagnostics). Persistently elevated serum estradiol level outside the post-menopausal range was defined as: Serum estradiol \>10 pg/dl on two consecutive collections at least 4 weeks apart. 2. If baseline estradiol was \>10 pg/dl, subsequent levels \>10 pg/ml higher than baseline were considered a significant elevation outside the post-menopausal range.
measure
Persistently Elevated Serum Estradiol Level Outside the Post-menopausal Range
time Frame
12 Weeks

secondary Outcomes

description
serial measurements of serum estradiol (E2) by liquid chromatography tandem mass spectrometry (Quest Diagnostics)
measure
Serum Estradiol (E2)
time Frame
12 weeks
description
Serum estradiol assays sent to the UCSF clinical laboratory are sent out to Quest Diagnostics, which uses LC/MS for their ultra-sensitive estradiol assay. Samples were also sent to a specialized research lab in England which has developed an ultrasensitive assay using radioimmunoassay (RIA) after ether extraction (sensitivity limit of 3pmol/l) to quantify low levels of estradiol found in post-menopausal women
measure
Matched E2 by Commercial and Research (RIA) Analyses
time Frame
baseline, 4 weeks
description
By serum ultrasensitive total testosterone test (Quest Diagnostics)
measure
Total Testosterone Levels
time Frame
12 weeks
description
Cancer Rehabilitation Evaluation System (CARES) Sexual Dysfunction (SD) and Sexual Interest (SI) Subscales range from 0 to 4 and measure the severity of problems, with higher scores indicating more difficulty.
measure
Sexual Quality of Life
time Frame
Baseline, Week 4, Week 12
description
Participants were asked to respond to a Sexual Satisfaction One Item Measure which asked "Overall, how satisfactory to you is your sexual relationship with your partner?" Response options range from 1 (Extremely unsatisfactory) to 6 (Extremely satisfactory).
measure
Sexual Satisfaction
time Frame
Baseline, Week 4, Week 12
description
During a gynecologic exam, the vaginal epithelium was assessed by an examiner using the Vaginal Atrophy Scoring Scale to evaluate Rugae (lack of), Pallor (pinkness), Petechiae, Mucosal thinning, Dryness. Scores range from 0 (none) to 3 (severe); higher scores indicate less favorable outcomes.
measure
Change in Vaginal Epithelium Scores
time Frame
Baseline, 12 weeks

Full study description

brief Summary: The purpose of this clinical research study is to determine whether the ESTRING or a special preparation of a testosterone cream inserted vaginally are safe for use in breast cancer patients. This study will also evaluate if either of these treatments can improve symptoms of vaginal dryness or decreased sexual interest that are related to your treatment for breast cancer.
detailed Description: There is a growing body of scientific literature to suggest that sexual functioning is one of the most distressing problems experienced by breast cancer survivors. Vaginal dryness, dyspareunia (pain during sexual intercourse), and decreased libido are common complaints among breast cancer patients. With increasing use of aromatase inhibitors which are associated with a higher rate of vaginal dryness than tamoxifen, these problems are becoming even more prominent. This study will evaluate the safety and tolerability of the ESTRING and 1% testosterone cream administered vaginally as treatments for vaginal dryness and/or decreased libido in women receiving an aromatase inhibitor for early stage breast cancer.

Source references

references

citation
Melisko ME, Goldman ME, Hwang J, De Luca A, Fang S, Esserman LJ, Chien AJ, Park JW, Rugo HS. Vaginal Testosterone Cream vs Estradiol Vaginal Ring for Vaginal Dryness or Decreased Libido in Women Receiving Aromatase Inhibitors for Early-Stage Breast Cancer: A Randomized Clinical Trial. JAMA Oncol. 2017 Mar 1;3(3):313-319. doi: 10.1001/jamaoncol.2016.3904.
pmid
27832260
type
DERIVED

Source notices and limitations

Discovery and provenance

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ctgov-registry-1336d216cbd1bbff780dac70
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source kind
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source url
https://clinicaltrials.gov/api/v2/studies?query.cond=Vaginal+Cancer&filter.advanced=AREA%5BHasResults%5Dtrue&pageSize=1000&format=json&countTotal=true
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exact text
NCT00698035
start
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offset unit
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query cond
Vaginal Cancer
query disease state id
ds-vaginal-cancer
source file
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source kind
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source string sha256
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source url
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Preserved source evidence · Not medical advice