A Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial to Compare the Effects of 12 Weeks of Treatment With DR-2041(Synthetic Conjugated Estrogens, A) Vaginal Cream vs. Placebo Vaginal Cream on Vulvovaginal Atrophy in Healthy Postmenopausal Women
Trial Snapshot
- Phase
- Phase 3
- Status
- Completed
- Sponsor
- Duramed Research
- Enrollment
- 622
- Locations
- 1
- Primary Endpoint
- Mean Change in Vaginal pH
Study Overview
Brief Summary
This is a four-arm, randomized, double-blind, parallel group, placebo-controlled study to compare the effects of two doses of DR-2041(Synthetic Conjugated Estrogens, A) Vaginal Cream on vulvovaginal atrophy in postmenopausal women with or without a hysterectomy and/or oophorectomy.
Detailed Description
The study will include a screening period up to 4 weeks and a 12- week treatment period. The overall study duration for participants will be approximately 16 weeks. Study participants will undergo physical and gynecological exams, and blood tests for clinical laboratory assessments. All patients with a uterus will undergo transvaginal ultrasound.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Double (Participant, Investigator)
Eligibility Criteria
- Ages
- 30 Years to 80 Years (Adult, Older Adult)
- Sex
- Female
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Naturally or surgically menopausal
- •Moderate or severe symptoms of vaginal atrophy (ie, dryness, itching, pain, uncomfortable intercourse)
Exclusion Criteria
- •Known sensitivity or contraindication to estrogens or progestins
- •History or current diagnosis endometrial hyperplasia
- •Recent history of vaginal bleeding of unknown cause
- •Recent history or diagnosis of endometriosis
- •Any contraindication to estrogen therapy
Arms & Interventions
3
Intervention: Placebo (Other)
1
Intervention: DR-2041a (Drug)
2
Intervention: DR-2041b (Drug)
4
Intervention: Placebo (Other)
Outcomes
Primary Outcomes
Mean Change in Vaginal pH
Time Frame: Baseline to Week 12
Change= Week 12 vaginal pH - Baseline vaginal pH
Mean Change in the Symptom Identified by the Patient to be Most Bothersome
Time Frame: Baseline to Week 12
Change= Week 12 score - Baseline Score. The most bothersome symptom was derived from the subject self-assessment of vaginal atrophy, which consisted of 5 questions concerning severity of symptoms graded on a scale of 0-3(none, mild, moderate or severe) or 7 for not applicable.
Mean Change in Maturation Index
Time Frame: Baseline to Week 12
Change= Week 12 maturation index -baseline maturation index. Matuation index was calculated using the following equation: Maturation Index = (% Parabasal cells \* 0) + (% Intermediate Cells \* 0.5) + (% Superficial Cells \* 1.0)
Secondary Outcomes
- Safety and Tolerability of DR-2041 (Synthetic Conjugated Estrogens, A)(Up to Week 12)