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

A Multicenter, Randomized, Double-Blind, Placebo- and Active-Controlled Study of DVS-233 SR for Treatment of Vasomotor Symptoms Associated With Menopause

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00195546

Enrollment

465

Registered

2005-09-19

Start date

2005-04-30

Completion date

2006-01-31

Last updated

2007-06-01

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Menopause

Keywords

Menopause

Brief summary

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.

Interventions

DRUGDVS-233

Study design

Allocation

RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

FEMALE

Age

40 Years to 65 Years

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

Design outcomes

Primary

Measure	Time frame
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

Measure	Time frame
To assess the effects of DVS-233 SR and tibolone on changes from baseline in weight, breast pain, and health outcomes indicators.	—

Countries

Belgium, Croatia, Czechia, Finland, France, Hungary, Mexico, Netherlands, Poland, Romania, South Africa, Spain, Sweden, Ukraine, United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026