CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 17 enrolled
Drug / intervention
Tamoxifen +1 moredrug
Likely dose
Intravaginal tamoxifen vaginal insert (specific dose not provided in INTERVENTIONS or ARMS)AI-extracted
Key inclusion· 9
  • ✓Postmenopausal women aged 40-75 with BMI 18-34 kg/m2
  • ✓Postmenopausal status confirmed by 12 months spontaneous amenorrhea, or 6 months spontaneous amenorrhea with FSH >40 mIU/mL, or 6 weeks post-surgical bilateral oophorectomy
  • ✓Moderate-to-severe vulvar and vaginal atrophy with at least 1 symptom (vaginal dryness, irritation/itching, dysuria, dyspareunia, or vaginal bleeding with sexual activity) reported as moderate or severe
  • ✓Current or past history of sexual activity at least once per month, willing to engage in sexual activity 1+ time between Days 49-56
Key exclusion· 14
  • ✕History of or use of anticoagulant drugs for coagulopathies, thrombophilia, or thromboembolic disease (DVT, PE, stroke, TIA)
  • ✕Uncontrolled hypertension (SBP >180 or DBP >105 mmHg), Class 1 antiarrhythmics/digitalis use, NYHA >Class I heart failure, or MI within 12 months
  • ✕Abnormal cervical screening within 2 years (except HPV-negative atypical squamous cells)
  • ✕History of or current endometrial pathology (hyperplasia, carcinoma, polyp); benign polyp acceptable if no current evidence

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT05378269
NCT05378269Phase 2Completed
CompareCT.gov

Phase 1/2 Study of Intravaginal Tamoxifen (DARE-VVA1): Randomized, Double-blind, Placebo-controlled Study of Safety, Pharmacokinetics and Pharmacodynamics in Postmenopausal Participants With Moderate to Sever Vulvar and Vaginal Atrophy

Daré Bioscience, Inc.·interventional·Posted May 18, 2022·Updated Oct 21, 2024

In Brief

A Phase 2 clinical trial evaluating Tamoxifen and Placebo for Vulvar Atrophy. Completed, enrolled 17 participants across 2 sites.

Detailed Summary

The purpose of the study is to study the safety, PK and PD of Intravaginal Tamoxifen on postmenopausal women with vulvar vaginal atrophy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsVulvar Atrophy
CountriesAustralia
Collaborators--

Timeline

Phase 2CompletedFinished
20222023202420252026
First PostedMay 18, 2022
Enrollment StartNov 22, 2021
Primary CompletionDec 20, 2022
Study CompletionMar 1, 2023
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 4.1 years ago

Interventions

Tamoxifendrug

Tamoxifen vaginal insert

Placeboother

Placebo vaginal insert