N/A
Completed N=9
Effect of Increased Circulating Androgens on Granulosa Cell Responses to FSH.
Source: ClinicalTrials.gov NCT02389088 ↗Enrolled (actual)
9
Serious AEs
0.0%
Results posted
Sep 2015
Primary outcomePrimary: Estradiol During Phase I and Phase II — 451.7; 116; 247.2; 131.4 pmol/L
Summary
The purpose of this study is to evaluate the effect of increased circulating androgens on estradiol production by the granulosa cells in response to FSH stimulus.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Estradiol During Phase I and Phase II |
451.7; 116; 247.2; 131.4; 347.5; 401.4 | — |
| PRIMARY Inhibin B During Phase I and Phase II |
420.6; 87.9; 395.1; 85.2; 445.5; 390 | — |
| PRIMARY LH and FSH During Phase I and Phase II |
NA; 0.6; NA; 2.0; NA; NA | — |
| PRIMARY Testosterone, Androstenedione and 17-OH Progesterone During Phase I and Phase II |
NA; 0.6; NA; 0.8; NA; NA | — |
Eligibility Criteria
Inclusion Criteria
- Subjects will be determined to have PCOS based on clinical criteria such as history of irregular menses and clinical or laboratory evidence of hyperandrogenism.
- Subjects should not have been on any hormonal therapy or metformin for at least 2 months prior to study start.
Exclusion Criteria
- Women with hemoglobin less than 11gm/dl at screening evaluation.
- Women with untreated thyroid abnormalities
- Pregnant women
- Women with BMI>37
- Women with known sensitivity to the agent being used.
Data sourced from ClinicalTrials.gov (NCT02389088). 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. Informational only — not medical advice.