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Phase 2a Safety Study of a Vaginal Matrix Ring Containing Dapivirine in a Postmenopausal Female Population
This study will evaluate the safety of the dapivirine vaginal ring when inserts once every 4 weeks in postmenopausal women over 12 weeks of product use.
Details
| Lead sponsor | International Partnership for Microbicides, Inc. |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 96 |
| Start date | 2013-12 |
| Completion | 2015-04 |
Conditions
- Human Immunodeficiency Virus
Interventions
- Dapivirine Vaginal Ring
- Placebo Vaginal Ring
Primary outcomes
- Safety of Dapivirine (25 mg) Administered in a Silicone Elastomer Vaginal Matrix Ring in HIV-uninfected Postmenopausal Women, When Inserted Once Every 4 Weeks During 12 Weeks of Study Product Use — over 12-week period of use
Evidence of Grade 2 or higher genital, genitourinary and reproductive system AEs as defined by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, Dec 2004 (Clarification dated August 2009), Addendum 1, (Female Genital Grading Table for Use in Microbicide Studies) judged to be related to study product. Evidence of Grade 3 or higher AEs as defined by the Division of AIDS Table for Grading the Severity of Adult and Pediatric Adverse Events, Version 1.0, Dec 2004 (Clarification dated August 2009). DAIDS severity grades are defined as follows: * Grade 1 = mild * Grade 2 = moderate * Grade 3 = severe * Grade 4 = potentially life-threatening * Grade 5 = death
Countries
United States