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NCT00464971 Clinical Trial

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

Menopause Clinical Trial

Official title:
Evaluation of Safety and Efficacy of 17-Beta Estradiol in Treatment of Estrogen Deficiency-Derived Atrophic Vaginitis

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00464971
Other study ID # VAG/PD/012/USA
Secondary ID
Status Completed
Phase Phase 3
First received April 23, 2007
Last updated February 28, 2017
Start date January 31, 1995
Est. completion date November 30, 1996

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

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 102
Est. completion date November 30, 1996
Est. primary completion date November 30, 1996
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

- 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• estradiol, 25 mcg

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 over 12 months of treatment
Primary Safety: Long-term effect on the endometrium assessed through evaluation of endometrial biopsies. AEs, clinical laboratory data and serum hormone levels
Secondary Vaginal health, vaginal cytology and urethral cytology
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