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Progesterone Action on Endometrium of PCOS

NCT05062135 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 36

Last updated 2022-01-20

No results posted yet for this study

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.

Conditions

  • Polycystic Ovary
  • Progesterone Resistance

Interventions

DRUG

Progesterone 400 Mg Vaginal Suppository on PCOS

The same drug will be used in control group

Sponsors & Collaborators

  • University of Sao Paulo General Hospital

    lead OTHER

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
35 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2014-02-10
Primary Completion
2014-09-10
Completion
2019-04-21

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05062135 on ClinicalTrials.gov