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

• Status: Completed
• Trial end date: 1995-11-30
• Target enrollment: 0
• Participant gender: Female

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novo Nordisk A/S
• Treatments: Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Polyestradiol phosphate

Criteria

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