Trials / Completed
CompletedNCT02638337
Study to Evaluate Ospemifene in Patients With Moderate to Severe Vaginal Dryness Due to Menopause
A Phase 3, Randomized, Double-blind, Placebo-controlled Multicenter Study to Evaluate the Efficacy and Safety of Ospemifene in Patients With Moderate to Severe Vaginal Dryness, a Symptom of Vulvo-vaginal Atrophy (VVA) Due to Menopause
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 631 (actual)
- Sponsor
- Shionogi · Industry
- Sex
- Female
- Age
- 40 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The objective of this study is to evaluate the efficacy and safety of ospemifene 60 mg once daily (QD) compared with placebo in treatment of vulvo-vaginal atrophy (VVA) due to menopause in women with moderate to severe vaginal dryness as the most bothersome symptom (MBS) of VVA.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Ospemifene | 60 mg tablet |
| DRUG | Placebo | Tablet identical to the ospemifene tablet without drug |
Timeline
- Start date
- 2016-01-26
- Primary completion
- 2017-06-23
- Completion
- 2017-07-05
- First posted
- 2015-12-23
- Last updated
- 2019-04-02
- Results posted
- 2019-04-02
Source: ClinicalTrials.gov record NCT02638337. Inclusion in this directory is not an endorsement.