# 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

> **NCT01585558** · PHASE3 · COMPLETED · sponsor: **Shionogi** · enrollment: 180 (actual)

## Conditions studied

- Atrophy
- Vaginal Diseases

## Interventions

- **DRUG:** Ospemifene (Dose 1)
- **DRUG:** Ospemifene (Dose 2)
- **DRUG:** Placebo

## Key facts

- **NCT ID:** NCT01585558
- **Lead sponsor:** Shionogi
- **Sponsor class:** INDUSTRY
- **Phase:** PHASE3
- **Study type:** INTERVENTIONAL
- **Status:** COMPLETED
- **Start date:** 2006-05-16
- **Primary completion:** 2008-08-19
- **Final completion:** 2008-09-18
- **Target enrollment:** 180 (ACTUAL)
- **Last updated:** 2018-05-21

## Collaborators

- [object Object]

## Primary source

ClinicalTrials.gov registry: https://clinicaltrials.gov/study/NCT01585558

## Citation

> US National Library of Medicine, ClinicalTrials.gov registration NCT01585558, "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". Retrieved via AI Analytics 2026-06-02 from https://api.ai-analytics.org/clinical/NCT01585558. Licensed CC0.

---

*[Clinical trials dataset](/datasets/clinical-trials) · CC0 1.0*
