Menorrhagia Study in Women With Treatment-resistant Menorrhagia

Bayer

Status and phase: Completed; Phase 2

Conditions: Menorrhagia

Treatments: Drug: Placebo; Drug: Asoprisnil (BAY86-5294)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00288691

90955

304667

Details and patient eligibility

About

The aim of this study is to explore effects of the investigational product for the treatment of treatment-resistant menorrhagia without organic cause.

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: 26 patients

Sex: Female

Ages: 30 to 55 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients with treatment-resistant menorrhagia scheduled for hysterectomy.

Exclusion criteria

• Organic causes of menorrhagia
• Current hormone treatment

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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26 participants in 4 patient groups, including a placebo group

Arm 1

Experimental group

Treatment:

Drug: Asoprisnil (BAY86-5294)

Drug: Asoprisnil (BAY86-5294)

Drug: Asoprisnil (BAY86-5294)

Arm 2

Experimental group

Treatment:

Drug: Asoprisnil (BAY86-5294)

Drug: Asoprisnil (BAY86-5294)

Drug: Asoprisnil (BAY86-5294)

Arm 3

Experimental group

Treatment:

Drug: Asoprisnil (BAY86-5294)

Drug: Asoprisnil (BAY86-5294)

Drug: Asoprisnil (BAY86-5294)

Arm 4

Placebo Comparator group

Treatment:

Drug: Placebo