Clinical trial · Interventional
Effects of Androgen Blockade on Sensitivity of the GnRH Pulse Generator to Suppression by Estradiol and Progesterone
Effect of Androgen Blockade on Sensitivity of the GnRH Pulse Generator to Suppression by Estradiol and Progesterone in Hyperandrogenic Adolescent Girls (JCM021)
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Haven't enrolled participants since 2010
Summary
Brief summary (as posted)
The purpose of this study is to understand the effects of elevated male hormones in adolescent girls and how they effect the development of polycystic ovary syndrome (PCOS). If the investigators understand the effects of elevated male hormones levels in girls, the investigators may be able to better treat girls with elevated male hormone levels and perhaps even learn how to prevent the development of PCOS. Females with elevated levels of male hormones respond differently to estrace (estradiol) and progesterone than females with normal male hormone levels. The investigators will be giving you estrogen and progesterone to see how you respond after the male hormone has been blocked by a medication called flutamide.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Hyperandrogenism | — | UNRESOLVED | — |
| Polycystic Ovary Syndrome | — | UNRESOLVED | — |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| estrace | Drug | — | UNRESOLVED |
| Flutamide | Drug | Flutamide | ALIAS |
| Progesterone | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Flutamide, estrace, progesterone
- description
- For flutamide, subjects weighing \> 50 kg will receive 250 mg orally twice a day, and subjects weighing \< 50 kg will receive 125 mg orally twice a day for approximately 3 weeks. Subjects will be given oral estrace, 0.5-1 mg once a day for 7 days following the first overnight study admission. Subjects will be given oral progesterone suspension (20 mg/ml, 25-100 mg) three times a day at 0700, 1500, and 2300 hr for seven days following the first overnight study admission.
- interventionNames
- Drug: Flutamide
- Drug: Progesterone
- Drug: estrace
Primary outcomes (1)
- measure
- Slope of the Percent Change in Luteinizing Hormone (LH) Pulses as a Function of Day 7 Progesterone Level
- timeFrame
- 3 weeks after flutamide treatment
- description
- The primary outcome variable for the study is the slope of the percent change in LH pulses as a function of day 7 progesterone level.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 13 Years
- Maximum age
- 17 Years
Show eligibility criteria text
Inclusion Criteria: * Girls ages 13 to 17 * Tanner IV or V stage of puberty * Post-menarche * Hyperandrogenemic (total testosterone \> 0.4 ng/mL or free testosterone \> 35 pmol/L) with or without hirsutism * Normal aspartate aminotransferase/alanine aminotransferase (AST/ALT) (AST \< 35 U/L, ALT \< 55 U/L) * Hemoglobin \> 12 mg/dL or Hematocrit \> 36% * Normal screening labs (with exception of the expected hormonal abnormalities inherent in hyperandrogenemia) * Sexually active subjects must agree to abstain or use double barrier contraception during the study * Subjects must agree not to take any other medications during the course of the study without approval by the study investigators Exclusion Criteria: * Abnormal screening labs (with the exception of the expected hormonal abnormalities inherent in hyperandrogenemia) * Elevated AST/ALT (AST \> 35 U/L, ALT \> 55 U/L) * Hemoglobin \<12 mg/dL or hematocrit \< 36% * Weight \< 32 kg * History of liver disease, peanut allergy, deep venous thrombosis, breast cancer, endometrial cancer, or cervical cancer * Pregnant or breastfeeding * On medications known to affect the reproductive axis within 3 months of the study (including oral contraceptive pills, metformin, and spironolactone) * On medications known or likely to inhibit or induce CYP1A2 or CYP3A4 (please see "Restrictions on use of other drugs or treatments" section below for common examples of such drugs) * Are currently participating in another study or have been in one in the last 30 days.
References
Publications (0)
Data not yet available