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

Novo Nordisk

Status and phase: Completed; Phase 3

Conditions: Menopause; Postmenopausal Vaginal Atrophy

Treatments: Drug: estradiol, 25 mcg

Study type: Interventional

Funder types: Industry

Identifiers

NCT00464971

VAG/PD/012/USA

Details and patient eligibility

About

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.

Enrollment: 102 estimated patients

Sex: Female

Ages: 45 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)