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

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ClinicalTrials.gov Identifier: NCT03088046
Recruitment Status : Completed
First Posted : March 23, 2017
Last Update Posted : March 23, 2017
Sponsor:
Information provided by (Responsible Party):
Carlos Dosouto Capel, 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.


Condition or disease Intervention/treatment Phase
Anovulation Polycystic Ovary Syndrome Hyperandrogenism Drug: Micronized Progesterone Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 15 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Circulating Androgen Levels Are Not Affected by the Administration of Vaginal Micronized Progesterone for Withdrawal Bleeding in Patients With Polycystic Ovarian Syndrome
Actual Study Start Date : February 2014
Actual Primary Completion Date : February 2015
Actual Study Completion Date : February 2015


Arm Intervention/treatment
Micronized Progesterone
Administration of 200 mg of vaginal Micronized Progesterone (100 mg every 12 hours) for a 7-day course
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).





Primary Outcome Measures :
  1. Change in Total testosterone (TT) [ Time Frame: 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

  2. Change in free testosterone (FT) [ Time Frame: 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

  3. Change in sex hormone binding globulin (SHBG) [ Time Frame: 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)

  4. Change in dehydroepiandrosterone sulfate (DHEAS) [ Time Frame: 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)

  5. Change in androstenedione (A4) [ Time Frame: 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)

  6. Change in 17-OH progesterone [ Time Frame: 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



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Ages Eligible for Study:   18 Years to 35 Years   (Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Criteria

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

Additional Information:
Publications:
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Responsible Party: Carlos Dosouto Capel, Fellow in Reproductive Endocrinology, Institut Universitari Dexeus
ClinicalTrials.gov Identifier: NCT03088046     History of Changes
Other Study ID Numbers: SMD-2017-02
First Posted: March 23, 2017    Key Record Dates
Last Update Posted: March 23, 2017
Last Verified: March 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Polycystic Ovary Syndrome
Hyperandrogenism
Anovulation
Syndrome
Disease
Pathologic Processes
Ovarian Cysts
Cysts
Neoplasms
Ovarian Diseases
Adnexal Diseases
Genital Diseases, Female
Gonadal Disorders
Endocrine System Diseases
46, XX Disorders of Sex Development
Disorders of Sex Development
Urogenital Abnormalities
Adrenogenital Syndrome
Congenital Abnormalities
Progesterone
Androgens
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs