Study Evaluating Conjugated Estrogen Cream for Atrophic Vaginitis

This study has been completed.
Information provided by:
Wyeth is now a wholly owned subsidiary of Pfizer Identifier:
First received: August 25, 2005
Last updated: December 7, 2007
Last verified: December 2007

This protocol is designed to study the effect and safety of 2 low-dose regimens of conjugated estrogen cream (PVC) given vaginally in postmenopausal women with atrophic vaginitis.

Condition Intervention Phase
Atrophic Vaginitis
Drug: PVC (daily for 21 days, 7 days off)
Drug: PVC (twice weekly)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double-Blind
Primary Purpose: Treatment
Official Title: Efficacy and Safety of 2 Low-Dose Regimens of Conjugated Estrogen Cream Administered Vaginally in Postmenopausal Women With Atrophic Vaginitis

Resource links provided by NLM:

Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • To evaluate the efficacy of 2 low dose regimens of conjugated estrogen in the treatment of atrophic vaginitis from baseline to 12 weeks.

Secondary Outcome Measures:
  • To evaluate change from baseline in the percentage of superficial cells, symptom relief, the effect of both regimens on endometrial stimulation and genital health.

Estimated Enrollment: 480
Study Start Date: August 2005
Study Completion Date: September 2007

Ages Eligible for Study:   45 Years to 80 Years
Genders Eligible for Study:   Female

Inclusion Criteria:

Generally healthy postmenopausal women with symptoms of atrophic vaginitis including vaginal dryness, vaginal itching, vaginal burning, and/or painful intercourse.

The subject must have a clinical diagnosis of atrophic vaginitis and an intact uterus.

Exclusion Criteria:

Women who do not have a clinical diagnosis of atrophic vaginitis.

  Contacts and Locations
Please refer to this study by its identifier: NCT00137371

  Show 49 Study Locations
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
  More Information

No publications provided Identifier: NCT00137371     History of Changes
Other Study ID Numbers: 0713S5-413
Study First Received: August 25, 2005
Last Updated: December 7, 2007
Health Authority: Canada: Health Canada
United States: Food and Drug Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Additional relevant MeSH terms:
Vaginal Diseases
Genital Diseases, Female
Pathological Conditions, Anatomical
Estrogens, Conjugated (USP)
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions processed this record on April 17, 2014