Trials / Completed
CompletedNCT01585558
Long-Term Safety of 30 mg and 60 mg Oral Daily Dose of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women With Intact Uterus
Long-Term Safety of 30 mg and 60 mg Oral Daily Dose of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women With Intact Uterus: A 40 Week Randomized, Double Blind, Placebo Controlled, Follow-Up to Protocol 15-50310.
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 180 (actual)
- Sponsor
- Shionogi · Industry
- Sex
- Female
- Age
- 40 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The primary objective of the study was to assess the long-term safety of 30- and 60-mg daily doses of ospemifene in the treatment of Vulvar and Vaginal Atrophy (VVA) in postmenopausal women with an intact uterus.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ospemifene (Dose 1) | |
| DRUG | Ospemifene (Dose 2) | |
| DRUG | Placebo |
Timeline
- Start date
- 2006-05-16
- Primary completion
- 2008-08-19
- Completion
- 2008-09-18
- First posted
- 2012-04-26
- Last updated
- 2018-05-21
- Results posted
- 2013-06-28
Source: ClinicalTrials.gov record NCT01585558. Inclusion in this directory is not an endorsement.