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

Polycystic Ovary Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03088046
• Other study ID #: SMD-2017-02
• Status: Completed
• Phase: N/A
• First received: March 1, 2017
• Last updated: March 16, 2017
• Start date: February 2014
• Est. completion date: February 2015

Study information

• Verified date: March 2017
• Source: Institut Universitari Dexeus
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: February 2015
• Est. primary completion date: February 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Anovulation
• Hyperandrogenism
• Polycystic Ovary Syndrome
• Syndrome

Intervention

Drug:
• Micronized Progesterone
Anovulatory women with Polycystic ovary syndrome and clinical hyperandrogenism attended in our Hospital will participate in the study. A patient information sheet will be provided and written consent will be obtained. Patients who give written consent will participate in the trial. All patient information will be confidential and only be available to researches involved in the study. Blood samples will be collected at baseline (Sample #1) and between the 3rd and the 5th day of withdrawal after 7 days of 100mg vaginal MP every 12 hours of administration(Sample#2).

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Institut Universitari Dexeus

References & Publications (1)

Livadas S, Boutzios G, Economou F, Alexandraki K, Xyrafis X, Christou M, Zerva A, Karachalios A, Tantalaki E, Diamanti-Kandarakis E. The effect of oral micronized progesterone on hormonal and metabolic parameters in anovulatory patients with polycystic ovary syndrome. Fertil Steril. 2010 Jun;94(1):242-6. doi: 10.1016/j.fertnstert.2009.02.073. — View Citation

Outcome

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

External Links

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