Treatment of Hot Flushes in Asian Women With Ultra-low Dose Estradiol Patch

Bayer

Status and phase: Completed; Phase 3

Conditions: Hot Flashes

Treatments: Drug: Menostar (estradiol transdermal delivery system); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00185237

91441

309120

Details and patient eligibility

About

150 postmenopausal Asian women with vasomotor symptoms, after fulfilling the inclusion and exclusion criteria will be enrolled in the study. The women will be randomly assigned to one of two treatment groups (Menostar® or placebo), after which they will be asked to use a patch once a week for 12 weeks.

Full description

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer Schering Pharma AG, Germany.Bayer Schering Pharma AG, Germany is the sponsor of the trial.

Enrollment: 165 patients

Sex: Female

Ages: 45 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Evidence of postmenopausal status

Exclusion criteria

• Contraindication to estrogen therapy

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

165 participants in 2 patient groups, including a placebo group

Arm 1

Experimental group

Treatment:

Drug: Menostar (estradiol transdermal delivery system)

Arm 2

Placebo Comparator group

Treatment:

Drug: Placebo