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

Sponsor:	Duramed Research
Information provided by:	Duramed Research
ClinicalTrials.gov Identifier:	NCT00361569

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 III

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:

MedlinePlus related topics: Menopause

Drug Information available for: Estrogens, conjugated

U.S. FDA Resources

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

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:

NAMS- Menopause Guidebook This link exits the ClinicalTrials.gov site

NIH- Menopausal Hormone Therapy This link exits the ClinicalTrials.gov site

Publications:

Freedman M, Kaunitz AM, Reape KZ, Hait H, Shu H. Twice-weekly synthetic conjugated estrogens vaginal cream for the treatment of vaginal atrophy. Menopause. 2009 Jul-Aug;16(4):735-41.

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 February 09, 2012