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Completed

NCT Number: NCT00361569

A Clinical Trial to Evaluate the Safety and Efficacy of DR-2041(Synthetic Conjugated Estrogens, A) for Treatment of Vulvovaginal Atrophy

This is a four-arm, randomized, double-blind, parallel group, placebo-controlled study to compare the effects of two doses of DR-2041(Synthetic Conjugated Estrogens, A) Vaginal Cream on vulvovaginal atrophy in postmenopausal women with or without a hysterectomy and/or oophorectomy.

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Key information

Conditions

Menopause

Age range

30 year–80 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Duramed Investigational Site, Huntsville, Alabama, United States

Loading trial locations.

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 menopausal
  • 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 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

DR-2041a

Drug

1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter

Other names: Synthetic conjugated estrogens, A

DR-2041b

Drug

2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter

Other names: Synthetic conjugated estrogens, A

Placebo

Other

1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter

Primary outcomes

  1. Mean Change in the Symptom Identified by the Patient to be Most Bothersome

    Time frame: Baseline to Week 12

    Change= Week 12 score - Baseline Score. The most bothersome symptom was derived from the subject self-assessment of vaginal atrophy, which consisted of 5 questions concerning severity of symptoms graded on a scale of 0-3(none, mild, moderate or severe) or 7 for not applicable.

  2. Mean Change in Vaginal pH

    Time frame: Baseline to Week 12

    Change= Week 12 vaginal pH - Baseline vaginal pH

  3. Mean Change in Maturation Index

    Time frame: Baseline to Week 12

    Change= Week 12 maturation index -baseline maturation index. Matuation index was calculated using the following equation: Maturation Index = (% Parabasal cells * 0) + (% Intermediate Cells * 0.5) + (% Superficial Cells * 1.0)

Secondary outcomes

  1. Safety and Tolerability of DR-2041 (Synthetic Conjugated Estrogens, A)

    Time frame: Up to Week 12

    Any adverse event reported from the beginning of the 28-day screening through the subject's last report.

Sponsors and collaborators

Lead sponsor

Duramed Research

Industry

Registry information

Official study title

A Randomized, Multicenter, Double-Blind, Placebo-Controlled Trial to Compare the Effects of 12 Weeks of Treatment With DR-2041(Synthetic Conjugated Estrogens, A) Vaginal Cream vs. Placebo Vaginal Cream on Vulvovaginal Atrophy in Healthy Postmenopausal Women

Important dates

Study start
2006
Primary completion
2007
Study completion
2007
First posted
Aug 8, 2006
Registry last updated
Apr 20, 2015

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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