Status:
COMPLETED
Vaginal Heat Wash-out (HWO) in 4 Groups of Women (Pre- and Postmenopausal With and Without Female Sexual Arousal Disorder (FSAD)).
Lead Sponsor:
Pfizer
Conditions:
Sexual Dysfunction, Physiological
Eligibility:
FEMALE
18-65 years
Phase:
PHASE1
Brief Summary
The Pfizer developed Heat Wash-Out (HWO) system is a software controlled electromechanical system designed to measure vaginal wall blood flow. A small vaginal probe is attached to a control unit. Outp...
Detailed Description
Medical Device Development
Eligibility Criteria
Inclusion
- Pre-menopausal women aged 18-40 (with and without FSAD) or
- Post-menopausal women aged 50-65 (with and without FSAD.
- FSAD must have been present for at least 6 months.
Exclusion
- Pregnant or lactating women (pre-menopausal population)
- Systemic Hormone Replacement Therapy (HRT) or Selective Estrogen Receptor Modulator (SERM) (postmenopausal population)
- Subjects with evidence or history of clinically significant hematological, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, psychiatric, neurologic disease or other major psychological or sexual disorder.
Key Trial Info
Start Date :
March 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2008
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00443248
Start Date
March 1 2007
End Date
October 1 2008
Last Update
May 28 2019
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Pfizer Investigational Site
Dulwich, South Australia, Australia, 5065
2
Pfizer Investigational Site
Nedlands, Western Australia, Australia, 6009