Ignite Creation Date:
2024-05-05 @ 5:03 PM
Last Modification Date:
2024-10-26 @ 9:27 AM
Study NCT ID:
NCT00375297
Status:
COMPLETED
Last Update Posted:
2006-09-12
First Post:
2005-09-11
Brief Title:
Study of Sildenafil for Treatment of SSRI-Antidepressant Sexual Dysfunction in Women
Sponsor:
University of New Mexico
Organization:
University of New Mexico
Study Overview
Official Title:
Randomized Double Blind Placebo Controlled Study of Sildenafil for Treatment of Serotonergic Reuptake Inhibitor Associated Sexual Dysfunction in Women With Major Depression Treated to Remission
Status:
COMPLETED
Status Verified Date:
2006-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This prospective double-blind placebo-controlled DBPC study assessed the efficacy of sildenafil in women with serotonin reuptake inhibitor antidepressant-associated sexual dysfunction SRI-AASD following the same protocol which previously established efficacy in men with SRI-AASD
Detailed Description:
This prospective double-blind placebo-controlled DBPC study assessed the efficacy of sildenafil in women with serotonin reuptake inhibitor antidepressant-associated sexual dysfunction SRI-AASD following the same protocol which previously established efficacy in men with SRI-AASD Women n100 with MDD-remission and SRI-AASD were randomized to receive sildenafil 50-100mg or placebo for 8 weeks followed by 8-weeks open-label extension Sexual function was assessed using the Clinical Global Impression-Sexual Function CGI-SF with positive response defined as a score 3 and UNM-SFI ASEX SFQ-FSD sexual function questionnaires Depression was monitored using the HAM-D17 Hypothalamic-pituitary-adrenal-gonadal hormones were measured at baseline and DB-endpoint
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
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 |
|---|---|---|---|
| Acc 4-37011 | None | None | None |