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:
Information provided by:
Teva Pharmaceutical Industries
ClinicalTrials.gov Identifier:
NCT00196378
First received: September 13, 2005
Last updated: August 30, 2013
Last verified: January 2010
  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:


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 ] [ 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
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: 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 Teva Pharmaceutical Industries

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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: August 30, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Teva Pharmaceutical Industries:
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 September 15, 2014