Skip to content
Triangle logo TriangleGet started
← Full study record

NCT00698035 · ADVERSE EVENTS

Adverse events

Vaginal Testosterone Cream vs ESTRING for Vaginal Dryness or Decreased Libido in Early Stage Breast Cancer Patients · Source last updated 2014-06-02

Results reported by the registry submitting party. Population, time horizon, units and missing values must be read together.

Adverse events occurred during the study; they are not necessarily caused by treatment. Serious events are not interchangeable with severe/grade 3–4 events. These safety populations may differ from efficacy populations.

Collection time frame
12 weeks
Other-event reporting threshold
1%
Participants affected / participants at risk, as reported
Safety groupSerious eventsOther eventsDeaths
Estring

Estring 2mg ring inserted vaginally once every 12 weeks

0 / 3910 / 39Not reported / Not reported
Testosterone Cream

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

0 / 3610 / 36Not reported / Not reported

Group identifiers: EG000: Estring · EG001: Testosterone Cream

Serious adverse events

Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

    Other reported adverse events

    Event terms and counts are source-reported; expand to read more. A reporting threshold may omit less frequent events.

    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Reproductive system and breast disorders
      source Vocabulary
      CTCAE (Unspecified)
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        39
        num Events
        4
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        36
        num Events
        2
      term
      Vaginal discharge
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Skin and subcutaneous tissue disorders
      source Vocabulary
      CTCAE (Unspecified)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        39
        num Events
        1
      2. group Id
        EG001
        num Affected
        5
        num At Risk
        36
        num Events
        5
      term
      Facial hair growth
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (Unspecified)
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        39
        num Events
        3
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        36
        num Events
        1
      term
      Hot flashes
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Reproductive system and breast disorders
      source Vocabulary
      CTCAE (Unspecified)
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        39
        num Events
        4
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        36
        num Events
        0
      term
      Vaginal itching or irritation
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Reproductive system and breast disorders
      source Vocabulary
      CTCAE (Unspecified)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        39
        num Events
        0
      2. group Id
        EG001
        num Affected
        3
        num At Risk
        36
        num Events
        3
      term
      Vaginal odor
    Complete source fields
    event Groups
    1. description
      Estring 2mg ring inserted vaginally once every 12 weeks
      id
      EG000
      other Num Affected
      10
      other Num At Risk
      39
      serious Num Affected
      0
      serious Num At Risk
      39
      title
      Estring
    2. 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
      id
      EG001
      other Num Affected
      10
      other Num At Risk
      36
      serious Num Affected
      0
      serious Num At Risk
      36
      title
      Testosterone Cream
    frequency Threshold
    1
    other Events
    1. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Reproductive system and breast disorders
      source Vocabulary
      CTCAE (Unspecified)
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        39
        num Events
        4
      2. group Id
        EG001
        num Affected
        2
        num At Risk
        36
        num Events
        2
      term
      Vaginal discharge
    2. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Skin and subcutaneous tissue disorders
      source Vocabulary
      CTCAE (Unspecified)
      stats
      1. group Id
        EG000
        num Affected
        1
        num At Risk
        39
        num Events
        1
      2. group Id
        EG001
        num Affected
        5
        num At Risk
        36
        num Events
        5
      term
      Facial hair growth
    3. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      General disorders
      source Vocabulary
      CTCAE (Unspecified)
      stats
      1. group Id
        EG000
        num Affected
        3
        num At Risk
        39
        num Events
        3
      2. group Id
        EG001
        num Affected
        1
        num At Risk
        36
        num Events
        1
      term
      Hot flashes
    4. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Reproductive system and breast disorders
      source Vocabulary
      CTCAE (Unspecified)
      stats
      1. group Id
        EG000
        num Affected
        4
        num At Risk
        39
        num Events
        4
      2. group Id
        EG001
        num Affected
        0
        num At Risk
        36
        num Events
        0
      term
      Vaginal itching or irritation
    5. assessment Type
      SYSTEMATIC_ASSESSMENT
      organ System
      Reproductive system and breast disorders
      source Vocabulary
      CTCAE (Unspecified)
      stats
      1. group Id
        EG000
        num Affected
        0
        num At Risk
        39
        num Events
        0
      2. group Id
        EG001
        num Affected
        3
        num At Risk
        36
        num Events
        3
      term
      Vaginal odor
    time Frame
    12 weeks

    Download exact source JSON → · Snapshot ctgov-results-25a395029948b04d52b1253f

    Preserved source evidence · Not medical advice