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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00361569
Recruitment Status : Completed
First Posted : August 8, 2006
Results First Posted : April 14, 2009
Last Update Posted : April 20, 2015
Sponsor:
Information provided by:

Study Description
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.

Condition or disease Intervention/treatment Phase
Menopause Drug: DR-2041a Drug: DR-2041b Other: Placebo Phase 3

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  (Clinical Trial)
Actual Enrollment : 622 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : August 2006
Primary Completion Date : September 2007
Study Completion Date : September 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Experimental: 1 Drug: DR-2041a
1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
Other Name: Synthetic conjugated estrogens, A
Experimental: 2 Drug: DR-2041b
2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter
Other Name: Synthetic conjugated estrogens, A
Placebo Comparator: 3 Other: Placebo
1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter
Placebo Comparator: 4 Other: Placebo
2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter


Outcome Measures

Primary Outcome Measures :
  1. 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.

  2. Mean Change in Vaginal pH [ Time Frame: Baseline to Week 12 ]
    Change= Week 12 vaginal pH - Baseline vaginal pH

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


Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00361569


  Show 97 Study Locations
Sponsors and Collaborators
Duramed Research
Investigators
Study Chair: Duramed Protocol Chair Duramed Research, Inc.
More Information

Additional Information:
Publications:
Responsible Party: Duramed Protocol Chair, Duramed Research, Inc.
ClinicalTrials.gov Identifier: NCT00361569     History of Changes
Other Study ID Numbers: DR-CEN-302
First Posted: August 8, 2006    Key Record Dates
Results First Posted: April 14, 2009
Last Update Posted: April 20, 2015
Last Verified: March 2015

Keywords provided by Teva Pharmaceutical Industries:
vaginal atrophy
vaginal dryness
vaginal itching
vaginal pain

Additional relevant MeSH terms:
Atrophy
Pathological Conditions, Anatomical
Estrogens
Estrogens, Conjugated (USP)
Estrogens, conjugated synthetic A
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs