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Completed

NCT Number: NCT00196378

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

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.

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Key information

Conditions

Menopause Dyspareunia Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Diseases, Male Male Urogenital Diseases Mental Disorders Sexual Dysfunction, Physiological Sexual Dysfunctions, Psychological Urogenital Diseases

Age range

30 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Duramed Investigational Site, Huntsville, Alabama, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Synthetic Conjugated estrogens, B

Drug

1 (0.3mg) tablet daily

Other names: Enjuvia

Placebo

Other

1 tablet daily

Primary outcomes

  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 outcomes

  1. Safety and tolerability of Enjuvia

    Time frame: Duration of study

Sponsors and collaborators

Lead sponsor

Duramed Research

Industry

Registry information

Official study 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

Important dates

Study start
2004
Primary completion
2006
Study completion
2006
First posted
Sep 20, 2005
Registry last updated
Sep 2, 2013

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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