Circulating Androgen Levels Are Not Affected by the Administration of Vaginal Micronized Progesterone for Withdrawal Bleeding in Patients With Polycystic Ovarian Syndrome

Not Applicable

Completed

• Conditions: Anovulation; Polycystic Ovary Syndrome; Hyperandrogenism
• Interventions: Drug: Micronized Progesterone

• Registration Number: NCT03088046
• Lead Sponsor: Institut Universitari Dexeus

Brief Summary

Hormonal evaluation of women who are suspected of having Polycystic ovary syndrome (PCOS) involves the measurement of basal levels of androgens and 17-hydroxyprogesterone (17-OHP), which are generally used to establish the presence of hyperandrogenemia. In general, these levels are obtained during the follicular phase to maintain sampling uniformity and avoid spurious increases due to corpus luteum function. However, because most hyperandrogenic patients are oligo/amenorrheic, it is frequently necessary to administer a progestogen to induce withdrawal bleeding and properly time the blood sampling.

Several medications have been described to properly induce withdrawal bleeding , with medroxyprogesterone acetate (MPA) being the most widely use. However, synthetic compounds as MPA do not replicate precisely the constellation of biologic activities of the parent hormone and results in a temporary, albeit clinically relevant, suppression in ovarian function and circulating androgen levels , in addition of several adverse side effects .

In this study, it is hypothesized that the administration of natural progesterone vaginally, which will avoid hepatic first pass, may result in significantly less hormonal suppression.

The authors test this hypothesis by prospectively determining the effect of vaginal micronized progesterone (OMP), administered for the induction of withdrawal bleeding, on the circulating androgen and 17-OHP levels in women with PCOS.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-02
• Primary Completion: 2015-02
• Study Completion: 2015-02
• Status Verified: 2017-03
• Study First Submitted: 2017-03-01
• Study First Submitted QC: 2017-03-16
• Last Update Submitted: 2017-03-16
• Study First Posted: 2017-03-23
• Last Update Posted: 2017-03-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 15

Inclusion Criteria

• Chronic ovulatory dysfunction, defined as intermenstrual intervals of >45 days or a total of <8 menstrual cycles per year
• Polycystic ovaries, defined as at least one ovary with >12 follicles between 2 and 9 mm or an ovarian volume >10 mL
• Clinical hyperandrogenism, defined by a Ferriman Gallwey score >8

Exclusion Criteria

• non-classic congenital adrenal hyperplasia,
• hyperprolactinemia
• thyroid dysfunction
• Oral contraceptives pills taken at least 3 months before the study

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Micronized Progesterone	Micronized Progesterone	Administration of 200 mg of vaginal Micronized Progesterone (100 mg every 12 hours) for a 7-day course

Primary Outcome Measures

Name	Time	Method
Change in dehydroepiandrosterone sulfate (DHEAS)	Blood samples will be collected at baseline (Sample #1) , and between the 3rd ad the 5th day of withdrawal after the treatment (sample #2)	Difference between first and second sample in dehydroepiandrosterone sulfate (DHEAS)
Change in Total testosterone (TT)	Blood samples will be collected at baseline (Sample #1) , and between the 3rd ad the 5th day of withdrawal after the treatment (sample #2)	Difference between first and second sample in Total testosterone
Change in free testosterone (FT)	Blood samples will be collected at baseline (Sample #1) , and between the 3rd ad the 5th day of withdrawal after the treatment (sample #2)	Difference between first and second sample in free testosterone
Change in sex hormone binding globulin (SHBG)	Blood samples will be collected at baseline (Sample #1) , and between the 3rd ad the 5th day of withdrawal after the treatment (sample #2)	Difference between first and second sample in sex hormone binding globulin (SHBG)
Change in 17-OH progesterone	Blood samples will be collected at baseline (Sample #1) , and between the 3rd ad the 5th day of withdrawal after the treatment (sample #2)	Difference between first and second sample in 17-OH progesterone
Change in androstenedione (A4)	BBlood samples will be collected at baseline (Sample #1) , and between the 3rd ad the 5th day of withdrawal after the treatment (sample #2)	Difference between first and second sample in androstenedione (A4)