N/A N=39 Diagnostic

Ovarian Morphology and Theca Cell Androgen Production in Women With Polycystic Ovary Syndrome (PCOS)

Polycystic Ovary Syndrome

Bottom Line

View on ClinicalTrials.gov: NCT02145247 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Aug 2019

Primary outcome: Primary: Percent Change of 17-OHP Levels From Baseline — 67; 140 percent change

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: hCG (Drug)
Age: Adult · 18+ yrs
Sex: Female
Sponsor: University of California, San Diego
Primary completion: Feb 2017

Outcome Measures

Outcome	Result	p-value
PRIMARY Percent Change of 17-OHP Levels From Baseline	67; 140	—

Summary

Women with PCOS suffer from excess male hormone (androgen) production by the ovary. Androgen is made by cells that surround follicles that contain eggs. As the follicles (and eggs) grow and mature, there are more androgen producing cells. Women with PCOS have more follicles than normal women and therefore more androgen producing cells. While androgen production has been associated with the number of follicles, the relationship to the individual size of follicles in PCOS or normal women. This study intends to determine whether the size and number of ovarian follicles are correlated to androgen production in PCOS and normal women.

Eligibility Criteria

Inclusion Criteria

Subjects will be determined to have PCOS based on clinical history of irregular menses and clinical or laboratory evidence of hyperandrogenism and polycystic ovaries on ultrasound
Subjects should not have been on any hormonal therapy or metformin for at least 2 months prior to study start
Subjects will be determined to be normal controls if they have a clinical history of regular periods

Exclusion Criteria

Women with hemoglobin less than 11 gm/dl at screening evaluation
Women with untreated thyroid abnormalities
Pregnant women or women who are nursing
Women with BMI > 37
Women with known sensitivity to the agents being used
Women with diabetes, or renal, liver, or heart disease

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT02145247). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.