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

This study has been completed.
Sponsor:
Information provided by:
Duramed Research
ClinicalTrials.gov Identifier:
NCT00361569
First received: August 3, 2006
Last updated: January 14, 2010
Last verified: January 2010
  Purpose

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 Intervention Phase
Menopause
Drug: DR-2041a
Drug: DR-2041b
Other: Placebo
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Duramed Research:

Primary Outcome Measures:
  • Mean Change in the Symptom Identified by the Patient to be Most Bothersome [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
  • Mean Change in Vaginal pH [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]
  • Mean Change in Maturation Index [ Time Frame: Baseline to Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Safety and Tolerability of DR-2041 (Synthetic Conjugated Estrogens, A) [ Time Frame: Up to Week 12 ] [ Designated as safety issue: Yes ]

Enrollment: 622
Study Start Date: August 2006
Study Completion Date: September 2007
Primary Completion Date: September 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   30 Years to 80 Years
Genders 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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: August 3, 2006
Results First Received: December 22, 2008
Last Updated: January 14, 2010
Health Authority: United States: Food and Drug Administration

Keywords provided by Duramed Research:
vaginal atrophy
vaginal dryness
vaginal itching
vaginal pain

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

ClinicalTrials.gov processed this record on July 20, 2014