A Clinical Trial to Evaluate the Safety and Efficacy of Enjuvia 0.3 mg for the Treatment of Vulvovaginal Atrophy - Full Text View

Purpose

This is a two-arm, randomized, double-blind, parallel-group, placebo-controlled study to evaluate the efficacy of Enjuvia 0.3 mg tablets for the treatment of moderate to severe symptoms of vulvovaginal atrophy in postmenopausal women with or without a hysterectomy and/or oophorectomy.

Condition	Intervention	Phase
Menopause	Drug: Synthetic Conjugated estrogens, B 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 Evaluate the Efficacy and Safety of Synthetic Conjugated Estrogens, B (Enjuvia) 0.3 mg Tablets for the Treatment of Vulvovaginal Atrophy in Healthy Postmenopausal Women

Resource links provided by NLM:

MedlinePlus related topics: Menopause

Drug Information available for: Estrogens, conjugated Estrogens, conjugated synthetic B

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: Randomization to Week 12 ] [ Designated as safety issue: No ]
Mean change in vaginal pH [ Time Frame: Randomization to Week 12 ] [ Designated as safety issue: No ]
Mean change in maturation index [ Time Frame: Randomization to Week 12 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Safety and tolerability of Enjuvia [ Time Frame: Duration of study ] [ Designated as safety issue: Yes ]

Estimated Enrollment:	300
Study Start Date:	November 2004
Study Completion Date:	February 2006
Primary Completion Date:	February 2006 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1	Drug: Synthetic Conjugated estrogens, B 1 (0.3mg) tablet daily Other Name: Enjuvia
Placebo Comparator: 2	Other: Placebo 1 tablet daily

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 postmenopausal
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 of 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: NCT00196378

Show 38 Study Locations

Sponsors and Collaborators

Duramed Research

Investigators

Study Chair:

Duraemd Protocol Chair

Duramed Research, Inc.

More Information

No publications provided by Duramed Research

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Simon JA, Reape KZ, Wininger S, Hait H. Randomized, multicenter, double-blind, placebo-controlled trial to evaluate the efficacy and safety of synthetic conjugated estrogens B for the treatment of vulvovaginal atrophy in healthy postmenopausal women. Fertil Steril. 2008 Oct;90(4):1132-8. Epub 2007 Dec 3.

Responsible Party:	Duramed Protocol Chair, Duramed Research, Inc.
ClinicalTrials.gov Identifier:	NCT00196378 History of Changes
Other Study ID Numbers:	DR-ENJ-301
Study First Received:	September 13, 2005
Last Updated:	January 8, 2010
Health Authority:	United States: Food and Drug Administration

Keywords provided by Duramed Research:

vaginal atrophy
vaginal dryness
vaginal itching
vaginal pain
dyspareunia

Additional relevant MeSH terms:

Atrophy
Pathological Conditions, Anatomical
Estrogens, Conjugated (USP)
Estrogens
Estrogens, conjugated synthetic A

Estrogens, conjugated synthetic B
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 16, 2013