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

NCT03088046 | Completed

• 1 other identifier: SMD-2017-02
• Study Type: interventional
• Target: 15
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Anovulation; Polycystic Ovary Syndrome; Hyperandrogenism

Outcome Measures

Primary Outcomes (6)

• 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)

• 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)

• 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)

• 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)

• 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)

• 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)

Study Arms (1)

Micronized Progesterone

OTHER

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

Drug: Micronized Progesterone

Interventions

Micronized Progesterone DRUG

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).

Micronized Progesterone

Eligibility Criteria

• Age: 18 Years - 35 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Fundacion Dexeus: lead

Related 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. Epub 2009 May 5.

  PMID: 19409554 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Anovulation; Polycystic Ovary Syndrome; Hyperandrogenism

Interventions

Progesterone

Condition Hierarchy (Ancestors)

Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Gonadal Disorders; Endocrine System Diseases; Ovarian Cysts; Cysts; Neoplasms; 46, XX Disorders of Sex Development; Disorders of Sex Development; Urogenital Abnormalities; Adrenogenital Syndrome; Male Urogenital Diseases; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Corpus Luteum Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Progesterone Congeners; Gonadal Steroid Hormones

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Fellow in Reproductive Endocrinology

Study Record Dates

• First Submitted: March 1, 2017
• First Posted: March 23, 2017
• Study Start: February 1, 2014
• Primary Completion: February 1, 2015
• Study Completion: February 1, 2015
• Last Updated: March 23, 2017

Record last verified: 2017-03

Data Sharing

• IPD Sharing: Will not share