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NCT02413008 · FLOW

Participant flow

A Clinical Trial to Assess the Safety of 0.005 % Estriol Vaginal Gel in Hormone Receptor-Positive Postmenopausal Women With Early Stage Breast Cancer in Treatment With Aromatase Inhibitor in the Adjuvant Setting · Source last updated 2019-08-05

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

groups
  1. description
    Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel, containing 50 Mcg of estriol Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration
    id
    FG000
    title
    0.005% Estriol Vaginal Gel
  2. description
    Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel. Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration Placebo
    id
    FG001
    title
    Placebo Vaginal Gel
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        50
      2. group Id
        FG001
        num Subjects
        11
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        43
      2. group Id
        FG001
        num Subjects
        9
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        2
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
After Inform Consent signature and prior randomization the following data was collected for subject's eligibility: Medical and surgical history and demographics; physical examination, ECOG PS, hematology, blood chemistry, urine test, transvaginal ultrasound, Blood (serum) samples for FSH and LH determination and evaluation of vaginal dryness.
recruitment Details
The study had an initial safety phase of the trial started on March 30th, 2015; the treatment phase of the trial started in October 16th, 2015 and the study ended globally on February 10th, 2017
Complete source fields
groups
  1. description
    Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel, containing 50 Mcg of estriol Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration
    id
    FG000
    title
    0.005% Estriol Vaginal Gel
  2. description
    Route: Vaginal. Administration by an applicator inserted deep inside the vagina Dose: 1 g of gel. Dosage schedule: Weeks 1-3: single daily application Weeks 4-12: twice weekly administration Placebo
    id
    FG001
    title
    Placebo Vaginal Gel
periods
  1. milestones
    1. achievements
      1. group Id
        FG000
        num Subjects
        50
      2. group Id
        FG001
        num Subjects
        11
      type
      STARTED
    2. achievements
      1. group Id
        FG000
        num Subjects
        43
      2. group Id
        FG001
        num Subjects
        9
      type
      COMPLETED
    3. achievements
      1. group Id
        FG000
        num Subjects
        7
      2. group Id
        FG001
        num Subjects
        2
      type
      NOT COMPLETED
    title
    Overall Study
pre Assignment Details
After Inform Consent signature and prior randomization the following data was collected for subject's eligibility: Medical and surgical history and demographics; physical examination, ECOG PS, hematology, blood chemistry, urine test, transvaginal ultrasound, Blood (serum) samples for FSH and LH determination and evaluation of vaginal dryness.
recruitment Details
The study had an initial safety phase of the trial started on March 30th, 2015; the treatment phase of the trial started in October 16th, 2015 and the study ended globally on February 10th, 2017

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Preserved source evidence · Not medical advice