A Clinical Trial to Evaluate the Safety and Efficacy of DR-2041(Synthetic Conjugated Estrogens, A) for Treatment of Vulvovaginal Atrophy

Study Overview
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Brief Summary
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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
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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.

Official Title
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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

Conditions
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Menopause

Intervention / Treatment
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* Drug: DR-2041a
* Drug: DR-2041b
* Other: Placebo
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: DR-2041a<br>* 1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter<br>* Other names: Synthetic conjugated estrogens, A;|
| Experimental: 2<br> | Drug: DR-2041b<br>* 2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter<br>* Other names: Synthetic conjugated estrogens, A;|
| Placebo Comparator: 3<br> | Other: Placebo<br>* 1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter<br>|
| Placebo Comparator: 4<br> | Other: Placebo<br>* 2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Change in the Symptom Identified by the Patient to be Most Bothersome | 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. | Baseline to Week 12 | 
| Mean Change in Vaginal pH | Change= Week 12 vaginal pH - Baseline vaginal pH | Baseline to Week 12 | 
| Mean Change in Maturation Index | 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) | Baseline to Week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability of DR-2041 (Synthetic Conjugated Estrogens, A) | Any adverse event reported from the beginning of the 28-day screening through the subject's last report. | Up to Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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vaginal atrophy, vaginal dryness, vaginal itching, vaginal pain