Trials / Withdrawn
WithdrawnNCT03740945
Effect of Intravaginal Prasterone on Symptoms of VVA in Women Under Treatment With an Aromatase Inhibitor for Breast Cancer
Effect of Intravaginal Prasterone (DHEA) on Moderate to Severe Symptoms of Vulvovaginal Atrophy Due to Menopause, in Women Under Treatment With an Aromatase Inhibitor for Breast Cancer - (Placebo-Controlled, Double Blind and Randomized Phase III Study)
- Status
- Withdrawn
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- EndoCeutics Inc. · Industry
- Sex
- Female
- Age
- 30 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to confirm the efficacy of intravaginal prasterone (DHEA) on moderate to severe (MS) and most bothersome symptoms (MBS) of vulvovaginal atrophy (VVA) due to natural, surgical or treatment-induced menopause, in women with breast cancer who are under treatment with an aromatase inhibitor.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Placebo | Daily administration of one placebo vaginal ovule at bedtime |
| DRUG | Prasterone (DHEA) | Daily administration of one prasterone vaginal ovule at bedtime |
Timeline
- Start date
- 2018-11-06
- Primary completion
- 2019-12-05
- Completion
- 2019-12-05
- First posted
- 2018-11-14
- Last updated
- 2020-07-31
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03740945. Inclusion in this directory is not an endorsement.