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

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ClinicalTrials.gov Identifier: NCT00196378
Recruitment Status : Completed
First Posted : September 20, 2005
Last Update Posted : September 2, 2013
Sponsor:
Information provided by:
Teva Pharmaceutical Industries

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Menopause Drug: Synthetic Conjugated estrogens, B 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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 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 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
Study Start Date : November 2004
Actual Primary Completion Date : February 2006
Actual Study Completion Date : February 2006

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Arms and Interventions
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Arm Intervention/treatment
Experimental: 1 Drug: Synthetic Conjugated estrogens, B
1 (0.3mg) tablet daily
Other Name: Enjuvia
Placebo Comparator: 2 Other: Placebo
1 tablet daily


Outcome Measures
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Primary Outcome Measures :
  1. Mean change in the symptom identified by the patient to be most bothersome [ Time Frame: Randomization to Week 12 ]
  2. Mean change in vaginal pH [ Time Frame: Randomization to Week 12 ]
  3. Mean change in maturation index [ Time Frame: Randomization to Week 12 ]

Secondary Outcome Measures :
  1. Safety and tolerability of Enjuvia [ Time Frame: Duration of study ]

Eligibility Criteria
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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Older Adult)
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
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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
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Study Chair: Duraemd Protocol Chair Duramed Research, Inc.
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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Responsible Party: Duramed Protocol Chair, Duramed Research, Inc.
ClinicalTrials.gov Identifier: NCT00196378     History of Changes
Other Study ID Numbers: DR-ENJ-301
First Posted: September 20, 2005    Key Record Dates
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:
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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