Study Evaluating DVS-233 SR for Treatment of Vasomotor Symptoms Associated With Menopause

Wyeth

Status and phase

Completed

Phase 3

Conditions

Menopause

Treatments

Drug: DVS-233

Study type

Interventional

Funder types

Industry

Identifiers

NCT00195546

3151A2-321

Details and patient eligibility

About

Primary: To assess the efficacy and safety of DVS-233 SR compared with placebo for treatment of vasomotor symptoms (VMS) associated with menopause and to compare the bleeding incidence of DVS-233 SR and tibolone. Secondary: To assess the effects of DVS-233 SR and tibolone on changes from baseline in weight, breast pain, and health outcomes indicators.

Enrollment

465 estimated patients

Sex

Female

Ages

40 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Postmenopausal women of age 40 to 65 seeking treatment for hot flashes with last natural menstrual period (LNMP) completed at least 12 months prior to screening.
Minimum of 7 moderate to severe hot flashes per day or 50 per week recorded for 7 consecutive days
Body Mass Index less than or equal to 34 kg/m2 using the nomograph for BMI.

Exclusion criteria

History, presence, or suspicion of estrogen-dependent neoplasia; Malignancy, or treatment for malignancy, within the previous 2 years.
Active or recent arterial thromboembolic disease; History of venous thromboembolism
History of cerebrovascular accident, stroke, or transient ischemic attack -
Presence of major depressive disorder, bipolar disorder, psychotic disorder, or generalized anxiety disorder requiring therapy
Persistent elevated blood pressure