Treatment of Vasomotor Symptoms in Korean Post Menopausal Women

Bayer

Status and phase: Completed; Phase 3

Conditions: Vasomotor Symptoms

Treatments: Drug: Placebo; Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00651599

308381

91354

Details and patient eligibility

About

Study to demonstrate that the therapeutic efficacy of Angeliq® is better than placebo in Korean postmenopausal women with hot flushes and other climacteric symptoms. Safety and tolerability of Angeliq.

Enrollment: 90 patients

Sex: Female

Ages: 45 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Postmenopausal Korean women suffering from hot flushes

Exclusion criteria

• Standard exclusion criteria for HRT clinical trials had to be obeyed, including current or history of hormone dependent malignant disease, thromboembolic disorders, abnormal cervical smear, undiagnosed vaginal bleeding.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

---

90 participants in 2 patient groups, including a placebo group

Arm 2

Placebo Comparator group

Treatment:

Drug: Placebo

Arm 1

Experimental group

Treatment:

Drug: Angeliq (Drospirenone/17ß-estradiol, BAY86-4891)