Efficacy and Safety of 17-Beta Estradiol in Treatment of Atrophic Vaginitis

Menopause Clinical Trial

Official title:

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study Comparing the Efficacy and Safety of 17-Beta Estradiol 10 Micrograms and 25 Micrograms (Vagifem) Doses in Treatment of Estrogen Deficiency-Derived Atrophic Vaginitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00465192
• Other study ID #: VAG/PD/009/USA
• Status: Completed
• Phase: Phase 3
• First received: April 23, 2007
• Last updated: February 28, 2017
• Start date: August 31, 1994
• Est. completion date: November 30, 1995

Study information

• Verified date: February 2017
• Source: Novo Nordisk A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This trial was conducted in the United States of America (USA). This trial aimed for a comparison between the effect of two different doses of estradiol on parameters related to efficacy and safety.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: November 30, 1995
• Est. primary completion date: November 30, 1995
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 45 Years to 80 Years

Eligibility

Inclusion Criteria:

• Generally healthy

• Postmenopausal

• Hysterectomized or non-hysterectomized

• Moderate or severe vaginal dryness and soreness

Exclusion Criteria:

• Known, suspected, or past history of breast cancer

• Known, suspected, or past history of hormone-dependent tumor

• Genital bleeding of unknown etiology

• Acute thrombophlebitis or thromboembolic disorders or a past history of these conditions, associated with previous estrogen use

• Vaginal infection

• Use of exogenous corticosteroids or sex hormones within 8 weeks of starting active treatment in study

• Use of vaginal, oral or vulvar homeopathic preparations within seven days of starting active treatment in study

• History of treatment with diethylstilbestrol

Related Conditions & MeSH terms

• Atrophic Vaginitis
• Atrophy
• Menopause
• Postmenopausal Vaginal Atrophy
• Vaginitis

Intervention

Drug:
• estradiol, 10 mcg

• estradiol, 25 mcg

• placebo

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Novo Nordisk A/S

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Relief of vaginal symptoms		following 12 weeks of treatment.
Secondary	Adverse events
Secondary	Hematology and chemisty tests, and endometrial biopsy
Secondary	Vaginal and urethral cytology, and grading of vaginal health

External Links

•   Clinical Trials at Novo Nordisk