drugset / Trial / NCT01428193
Effects of Androgen Blockade on Sensitivity of the GnRH Pulse Generator to Suppression by Estradiol and Progesterone
Terminated
4 enrolled
University of Virginia
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) · collab
NaSingle-groupOpen-labelBasic science
Summary
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.
Timeline
- Start
- 2006-09
- Primary completion
- 2017-08
- Completion
- 2017-08
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Estradiol | Other / unclassified | 0.5 mg | Oral |
| Subject | Estradiol | Other / unclassified | 1 mg | Oral |
| Subject | Progesterone | Other / unclassified | 25 mg | Oral |
| Subject | Progesterone | Other / unclassified | 100 mg | Oral |
| Subject | flutamide | Small molecule | 125 mg | Oral |
| Subject | flutamide | Small molecule | 250 mg | Oral |