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NCT03018106 · ClinicalTrials.gov registry record · Phase 4
Ospemifene vs. Conjugated Estrogens in the Treatment of Postmenopausal Sexual Dysfunction
A Phase 4 study, sponsored by Emory University.
- Terminated
- Registry status
- Phase 4
- Development phase
- 1
- Enrollment target
NCT03018106 is a Phase 4 study that was terminated before completion, run by Emory University. The registered enrollment target is 1 participants.
The verdict
NCT03018106, a Phase 4 study, was terminated before completion, sponsored by Emory University.
- TERMINATED
- Registry status
- Phase 4
- Development phase
- 1 participants
- Enrollment target
Study Summary
Vulvovaginal atrophy (VVA) is a condition that impacts up to 60% of the growing postmenopausal female population, and the most common symptom is dyspareunia. Vaginal estrogen is the most common treatment for VVA, but it only marginally improves overall sexual function, and many women and clinicians avoid using it because of the risks of exogenous estrogen use during menopause. Ospemifene is a non-estrogen selective estrogen receptor modulator (SERM) that is FDA-approved for treating dyspareunia related to VVA, and has shown superb improvements in overall sexual health. 104 women will be randomized to receive 12 weeks of 60mg oral ospemifene, taken daily, or 12 weeks of 0.5mg vaginal conjugated estrogens, which is placed vaginally twice per week. The improvements in sexual health and VVA symptom severity will be compared in each group. This study will help determine if ospemifene is a better treatment medication than conjugated estrogens.
Interventions
- DRUG Ospemifene
- DRUG Vaginal conjugated estrogens
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1 participants |
| Start Date | 2017-06-30 |
| Est. Completion | 2017-09-29 |
| Phase | Phase 4 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03018106
The ClinicalTrials.gov registry entry for NCT03018106 describes a study currently listed as terminated, categorized as Phase 4. The registered enrollment target is 1 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Emory University, which has 1,208 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Ospemifene is the first listed.
NCT03018106 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03018106 about?
NCT03018106 is a clinical study titled "Ospemifene vs. Conjugated Estrogens in the Treatment of Postmenopausal Sexual Dysfunction". Vulvovaginal atrophy (VVA) is a condition that impacts up to 60% of the growing postmenopausal female population, and the most common symptom is dyspareunia. Vaginal estrogen is the most common treatment for VVA, but it only marginally improves overall sexual function, and many women and clinicians ...
What is the current status of trial NCT03018106?
This trial is currently terminated. It is a Phase 4 study. The enrollment target is 1 participants. The study started on 2017-06-30. Estimated completion is 2017-09-29.
What interventions are being tested in trial NCT03018106?
The interventions under investigation include: Ospemifene (DRUG), Vaginal conjugated estrogens (DRUG).
Who is sponsoring clinical trial NCT03018106?
This trial is sponsored by Emory University, which has 1,208 total clinical trials registered on ClinicalTrials.gov.
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