Official Title: “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”

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.

Study Type: Interventional

Study Design: Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: September 2007

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.

Intervention(s) in this Clinical Trial

• Drug: DR-2041a
  • 1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
• Drug: DR-2041b
  • 2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
• Other: Placebo
  • 1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
• Other: Placebo
  • 2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: 1
• Experimental: 2
• Placebo Comparator: 3
• Placebo Comparator: 4

Primary Measures

• Mean Change in the Symptom Identified by the Patient to be Most Bothersome
  • Time Frame: Baseline to Week 12
    Safety Issue?: No
• Mean Change in Vaginal pH
  • Time Frame: Baseline to Week 12
    Safety Issue?: No
• Mean Change in Maturation Index
  • Time Frame: Baseline to Week 12
    Safety Issue?: No

Secondary Measures

• Safety and Tolerability of DR-2041 (Synthetic Conjugated Estrogens, A)
  • Time Frame: Up to Week 12
    Safety Issue?: Yes

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

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 30 Years

Maximum Age for this Clinical Trial: 80 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Duramed Research

Overall Clinical Trial Officials and Contacts

Duramed Protocol Chair Study Chair Duramed Research, Inc.  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00361569

Study ID Number: DR-CEN-302

ClinicalTrials.gov Identifier: NCT00361569

Health Authority: United States: Food and Drug Administration

NAMS- Menopause Guidebook

NIH- Menopausal Hormone Therapy