Evaluation of Safety and Efficacy of 17-Beta Estradiol in Treatment of Atrophic Vaginitis: An Extension Trial

• Status: Completed
• Trial end date: 1996-11-30
• Target enrollment: 0
• Participant gender: Female

Summary

This trial was conducted in the United States of America (USA). This trial aimed to evaluate safety and efficacy of 17-beta Estradiol in the treatment of atrophic vaginitis.

• 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

• Successful completion of the study VAG/PD/009/USA

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

• Subjects who had adverse events during the final visit, or discontinued prematurely, or were noncompliant in VAG/PD/009/USA

• Exposure to any investigational new drug (other than what was dispensed in VAG/PD/009/USA) within the previous 30 days