Ignite Creation Date:
2024-05-06 @ 3:19 PM
Last Modification Date:
2024-10-26 @ 1:47 PM
Study NCT ID:
NCT04597099
Status:
RECRUITING
Last Update Posted:
2023-11-02
First Post:
2020-10-11
Brief Title:
Androgen Blockade and Progesterone Augmentation of Gonadotropin Secretion
Sponsor:
University of Virginia
Organization:
University of Virginia
Study Overview
Official Title:
Ability of Androgen-receptor Blockade to Normalize Progesterone-induced Augmentation of Gonadotropin Secretion in PCOS CRM010
Status:
RECRUITING
Status Verified Date:
2023-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
CRM010
Brief Summary:
This study is trying to find out if flutamide a medication that blocks the effects of testosterone may help normalize an aspect of pituitary function specifically gonadotropin surge generation in PCOS This is a randomized placebo-controlled double-blinded crossover study The investigators hypothesize that in estradiol-pretreated women with PCOS acute progesterone augmentation of FSH release positive feedback will be enhanced by flutamide
Detailed Description:
Women with PCOS appear to exhibit impaired progesterone P4 augmentation of gonadotropin release positive feedback and this is at least partly independent of BMI differences To test more directly the role of hyperandrogenemiahyperandrogenism HA we will assess if the androgen-receptor blocker flutamide enhances P4 augmentation of gonadotropin release in estradiol E2-treated women with PCOS We will study 10 women with PCOS This is a randomized placebo-controlled double-blinded crossover study with subjects undergoing two assessments of P4 positive feedback - once after 4 weeks pretreatment with flutamide and once after 4-weeks pretreatment with placebo in random order We will assess P4 positive feedback via frequent sampling for 16 hours Subjects will be pretreated for 3 days prior to CRU admission with transdermal E2 02 mgday starting no earlier than cycle day 7 Subjects will be admitted to the CRU the evening of day 3 of E2 treatment Starting at 0200 h blood will be collected for 16 hours After 6 h of sampling 0800 h subjects will receive a single oral dose of P4 A second CRU admission - performed at least 2 months later to permit adequate washout of flutamide as needed - will be identical to the first except that placebo pretreatment will be exchanged for flutamide pretreatment or vice versa We will assess the P4-mediated augmentation of FSH release with secondary endpoints including the P4-mediated augmentation of LH release We hypothesize that in E2-pretreated women with PCOS acute P4 augmentation of FSH release positive feedback will be enhanced by androgen-receptor blockade flutamide
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| R01HD102060 | NIH | None | httpsreporternihgovquickSearchR01HD102060 |