ClinicalTrials.Veeva

Menu

Menorrhagia Study in Women With Treatment-resistant Menorrhagia

Bayer logo

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

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

Trial contacts and locations

0

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2024 Veeva Systems