Long-Term Safety of Ospemifene 60 mg Oral Daily Dose for the Treatment of Vulvar and Vaginal Atrophy (VVA) in Postmenopausal Women Without a Uterus

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

301 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-05-08

Study Completion Date

2008-12-22

Brief Summary

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The objective of the study was to assess the long-term safety of daily doses of ospemifene 60 mg in the treatment of vulvar and vaginal atrophy (VVA) in postmenopausal women without a uterus.

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Detailed Description

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Conditions

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Atrophy Vaginal Diseases

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Ospemifene 60 mg Oral Tablet

Participants will take one tablet of ospemifene 60 mg orally, once a day for 12 weeks.

Group Type EXPERIMENTAL

Ospemifene 60Mg Oral Tablet

Intervention Type DRUG

Interventions

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Ospemifene 60Mg Oral Tablet

Intervention Type DRUG

Other Intervention Names

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Osphena®

Eligibility Criteria

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Inclusion Criteria

* Postmenopausal women aged 40 to 80 years with a diagnosis of vulvar and vaginal atrophy (VVA) as assessed by vaginal pH, maturation index of vaginal smear, and self-reported symptoms at Baseline for Protocol 15-50310
* Did not have a uterus

Exclusion Criteria

* Had completed Protocol 15-50310 without any clinically significant abnormal findings at the end-of-study visit for Protocol 15-50310
* Provided written informed consent to participate in the study and agreed to follow dosing instructions and complete all required study visits

* Had clinically significant abnormal findings at the Week 12 End of Study visit for Protocol 15-50310
* Had any physical or mental condition which, in the opinion of the investigator, may have interfered with the subject's ability to comply with the study procedures

Minimum Eligible Age

40 Years

Maximum Eligible Age

80 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No