Efficacy and Tolerability of Angeliq in Thai Women

Bayer

Status and phase: Completed; Phase 4

Conditions: Postmenopause

Treatments: Drug: Estradiol/DRSP (Angeliq, BAY86-4891)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00185328

309367

91436

Details and patient eligibility

About

To evaluate the safety, tolerability, and efficacy of Angeliq in Thai post menopausal women with hot flushes and other climacteric symptoms.

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: 55 patients

Sex: Female

Ages: 45+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Postmenopausal women with hot flushes

Exclusion criteria

• Women with a contraindication for Hormone Replacement Therapy (HRT)

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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55 participants in 1 patient group

Arm 1

Experimental group

Treatment:

Drug: Estradiol/DRSP (Angeliq, BAY86-4891)