CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 36 enrolled
Drug / intervention
Progesterone 400 Mg Vaginal Suppository on PCOSdrug
Likely dose
Progesterone 400 Mg Vaginal Suppository on PCOSfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05062135
NCT05062135N/ACompleted

Abnormalities of the Endometrium Persist Despite Adequate Progesterone Supplementation in the Polycystic Ovary Syndrome

University of Sao Paulo General Hospital·interventional·Posted Sep 30, 2021·Updated Jan 20, 2022

In Brief

A clinical study evaluating Progesterone 400 Mg Vaginal Suppository on PCOS for Polycystic Ovary and Progesterone Resistance. Completed, enrolled 36 participants.

Detailed Summary

Objective: To study the influence of metabolic factors on the action of progesterone on the endometrium of women with PCOS. Design: A prospective open-label clinical trial. Setting: Participants were recruited from an outpatient reproductive endocrinology clinic at an academic tertiary medical care center from 2014 to 2019. Subjects: To assess the sole effect of progesterone (P4) on the endometrium we studied amenorrheic (cycles\> 90 days) women with PCOS (n=23), comparing them to healthy eumenorrheic control women ( n=13). Intervention(s): All subjects underwent an endometrial biopsy (EB) in the follicular phase of the first study cycle. They were then treated with micronized P4 (400 mg/day x 10 days intravaginally) from days 14-28 of the cycle, and a second EB was performed between days 20-24 of the cycle (second phase). Main Outcome Measure(s): EB samples were analyzed under light microscopy for histomorphometric analysis.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
Countries--
Collaborators--

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedSep 30, 2021
Enrollment StartFeb 10, 2014
Primary CompletionSep 10, 2014
Study CompletionApr 21, 2019
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 4.8 years ago

Interventions

Progesterone 400 Mg Vaginal Suppository on PCOSdrug

The same drug will be used in control group