Trials / Completed
CompletedNCT01586364
Long-Term Safety of Ospemifene 60 mg Oral Daily Dose for the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women Without a Uterus
Long-Term Safety of Ospemifene 60 mg Oral Daily Dose for the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women Without a Uterus: A 52-Week Open-Label Follow-Up to Protocol 15-50310
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 301 (actual)
- Sponsor
- Shionogi · Industry
- Sex
- Female
- Age
- 40 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The objective of the study was to assess the long-term safety of daily doses of ospemifene 60 mg in the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women without a uterus.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ospemifene 60Mg Oral Tablet |
Timeline
- Start date
- 2006-05-08
- Primary completion
- 2008-11-21
- Completion
- 2008-12-22
- First posted
- 2012-04-26
- Last updated
- 2018-05-21
- Results posted
- 2013-06-28
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT01586364. Inclusion in this directory is not an endorsement.