Study to Investigate Effect of Sildenafil on Clitoral Engorgement as Measured by Magnetic Resonance Imaging (MRI) in Pre-menopausal Women With Female Sexual Arousal Disorder
Sponsor
Pfizer's Upjohn has merged with Mylan to form Viatris Inc. (Industry)
Overall Status
Completed
CT.gov ID
NCT00640458
Collaborator
(none)
20
3
2
35
6.7
0.2
Study Details
Study Description
Brief Summary
The purpose of this study is to investigate the effect of 100 mg sildenafil on clitoral engorgement in pre-menopausal women, as well as examining the safety and toleration of the drug.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 2 |
Study Design
Study Type:
Interventional
Actual Enrollment
:
20 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Primary Purpose:
Treatment
Official Title:
A Double Blind, Placebo Controlled 2-way Cross-over Study to Assess the Clitoral Engorgement Response as Measured by Non-contrast Magnetic Resonance Imaging (MRI) in Women With Female Sexual Arousal Disorder (FSAD) When Administered a Single Dose of Sildenafil (100mg) Followed by Audio/Visual Sexual Stimulation
Study Start Date
:
Apr 1, 2004
Actual Study Completion Date
:
Mar 1, 2007
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Placebo Comparator: Placebo Study Period 1 or 2 |
Drug: Placebo
|
| Experimental: Experimental Study Period 1 or 2 |
Drug: Sildenafil 100 mg
|
Outcome Measures
Primary Outcome Measures
- To determine the % of subjects who respond within 30 minutes of dosing by achieving an increase in clitoral engorgement >50% from baseline measured by MRI following audio/visual sexual stimulation in females with FSAD. [Up to 30 minutes post-dose]
Secondary Outcome Measures
- To determine the % of subjects who respond to sildenafil 100mg by achieving an increase in clitoral engorgement >50% from baseline within 40, 50 and 60 minutes of dosing respectively. [Up to 60 minutes post-dose]
- To assess safety and toleration of sildenafil 100mg by adverse event monitoring, laboratory safety testing and physical examination findings. [30 days post-dose]
- Assess plasma levels of sildenafil and metabolite [Day of dosing]
Eligibility Criteria
Criteria
Ages Eligible for Study:
18 Years
to 45 Years
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
Inclusion Criteria:
- Pre-menopausal women aged 18-45 with a primary diagnosis of Female Sexual Arousal Disorder for at least 6 months prior to entering the study. The FSAD could have been associated with female orgasmic disorder (FOD) and/or superficial or introital dyspareunia.
Exclusion Criteria:
-
Subjects with hypoactive sexual desire disorder.
-
Subjects not using an acceptable mean of contraception for the duration of the study.
-
Subjects who were prescribed and/or taking medication which were contraindicated or cautioned with concomitant intake of sildenafil.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Pfizer Investigational Site | Seattle | Washington | United States | 98105 |
| 2 | Pfizer Investigational Site | Seattle | Washington | United States | 98195-6465 |
| 3 | Pfizer Investigational Site | Nedlands | Western Australia | Australia | 6009 |
Sponsors and Collaborators
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
Investigators
- Study Director: Pfizer CT.gov Call Center, Pfizer
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
None provided.Responsible Party:
Pfizer's Upjohn has merged with Mylan to form Viatris Inc.
ClinicalTrials.gov Identifier:
NCT00640458
Other Study ID Numbers:
- A1481174
First Posted:
Mar 21, 2008
Last Update Posted:
Feb 1, 2021
Last Verified:
Jan 1, 2021
Additional relevant MeSH terms: