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

This study has been completed.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00196378

First Posted: September 20, 2005

Last Update Posted: September 2, 2013

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.

Information provided by:

Teva Pharmaceutical Industries

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 Intervention Model: Parallel Assignment Masking: Double (Participant, 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:

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

U.S. FDA Resources

Further study details as provided by Teva Pharmaceutical Industries:

Primary Outcome Measures:

Mean change in the symptom identified by the patient to be most bothersome [ Time Frame: Randomization to Week 12 ]
Mean change in vaginal pH [ Time Frame: Randomization to Week 12 ]
Mean change in maturation index [ Time Frame: Randomization to Week 12 ]

Secondary Outcome Measures:

Safety and tolerability of Enjuvia [ Time Frame: Duration of study ]


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

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 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

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): NCT00196378

Show 38 Study Locations

Sponsors and Collaborators

Duramed Research

Investigators


Study Chair:	Duraemd Protocol Chair	Duramed Research, Inc.

More Information

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
First Submitted:	September 13, 2005
First Posted:	September 20, 2005
Last Update Posted:	September 2, 2013
Last Verified:	January 2010

Keywords provided by Teva Pharmaceutical Industries:


vaginal atrophy vaginal dryness vaginal itching vaginal pain dyspareunia

Additional relevant MeSH terms:


Atrophy Pathological Conditions, Anatomical Estrogens Estrogens, Conjugated (USP) Estrogens, conjugated synthetic A	Estrogens, conjugated synthetic B Hormones Hormones, Hormone Substitutes, and Hormone Antagonists Physiological Effects of Drugs

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