9 completed, 1 terminated. 6 Phase 3, 3 Phase 4, 1 Phase 2.
| Phase | Trials | Status |
|---|---|---|
| Phase 3 | 6 | Completed 6 |
| Phase 4 | 3 | Completed 2, Terminated 1 |
| Phase 2 | 1 | Completed 1 |
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Tick up to 5 trials to compare them side by side (eligibility, arms, endpoints, adverse events) in a Literature Matrix.
| Trial | Phase | Status | Sponsor | Enrollment | Start | Updated |
|---|---|---|---|---|---|---|
| Effects of Ospemifene on Brain Activation Patterns in Women With Sexual Interest-arousal Disorders Ospemifene 60 mg, fMRI experiments - Vulvovaginal Signs and Symptoms, Genitourinary Syndrome of Menopause | Phase 4 | Completed | Hospital Clinic of Barcelona | 25 | 2021-11-01 | 2025-09-15 |
| Ospemifene vs. Conjugated Estrogens in the Treatment of Postmenopausal Sexual Dysfunction Ospemifene, Vaginal conjugated estrogens - Sexual Dysfunction, Physiological | Phase 4 | Terminated | Emory University | 1 | 2017-06-30 | 2018-01-23 |
| Study to Evaluate Ospemifene in Patients With Moderate to Severe Vaginal Dryness Due to Menopause Ospemifene, Placebo - Vaginal Dryness | Phase 3 | Completed | Shionogi | 631 | 2016-01-26 | 2019-04-02 |
| Vulvoscopy Changes of the Vulva, Vestibule and Vagina With Daily Ospemifene in Women With Dyspareunia From VVA Ospemifene - Vulvovaginal Atrophy, Dyspareunia | Phase 4 | Completed | Sue Goldstein | 10 | 2015-07-01 | 2019-04-02 |
| Efficacy and Safety of Ospemifene in the Treatment of Moderate to Severe Vaginal Dryness and Vaginal Pain Associated With Sexual Activity Ospemifene 60 mg, Placebo - Atrophy, Vaginal Diseases | Phase 3 | Completed | Shionogi | 919 | 2008-07-01 | 2018-05-18 |
| A Clinical Study to Evaluate the Safety of Ospemifene Ospemifene 60 mg, Placebo - Atrophy, Vaginal Diseases | Phase 3 | Completed | Shionogi | 426 | 2007-10-01 | 2018-05-18 |
| A Clinical Study to Evaluate the Efficacy and Safety of Ospemifene in the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women Placebo, Ospemifene 5 mg, Ospemifene 15 mg - Atrophy, Vaginal Diseases | Phase 2 | Completed | Shionogi | 126 | 2007-08-01 | 2013-06-28 |
| 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 Ospemifene (Dose 1), Ospemifene (Dose 2), Placebo - Atrophy, Vaginal Diseases | Phase 3 | Completed | Shionogi | 180 | 2006-05-16 | 2018-05-21 |
| 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 Ospemifene 60Mg Oral Tablet - Atrophy, Vaginal Diseases | Phase 3 | Completed | Shionogi | 301 | 2006-05-08 | 2018-05-21 |
| A Clinical Study to Evaluate Ospemifene in the Treatment of Vulvar and Vaginal Atrophy in Postmenopausal Women Ospemifene 30 mg, Ospemifene 60 mg, Placebo - Atrophy, Vaginal Diseases | Phase 3 | Completed | Shionogi | 826 | 2006-01-01 | 2013-06-28 |
Atrophy (6) · Vaginal Diseases (6) · Sexual Dysfunction, Physiological (2) · Coitus (1) · Dyspareunia (1)
Shionogi (7) · Emory University (1) · Hospital Clinic of Barcelona (1) · Sue Goldstein (1)
United States (2) · Spain (1)
Camil Castelo-Branco (1) · Gina Northington, MD, PhD (1) · Irwin Goldstein, MD (1)