Menorrhagia Study in Women With Treatment-resistant Menorrhagia

A Multi-center, Double-blind, Placebo-controlled, Randomized, Parallel Group Study to Evaluate the Effects of Different Doses of SH T 00127B in Women With Treatment-resistant Menorrhagia Aged 30 to 55 Years After Daily Oral Administration of Multiple Doses for 35 up to 50 Days

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00288691

Enrollment

Registered

2006-02-08

Start date

2001-11-30

Completion date

2004-01-31

Last updated

2014-12-30

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Menorrhagia

Keywords

Treatment-resistant menorrhagia

Brief summary

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

Detailed 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.

Interventions

DRUGAsoprisnil (BAY86-5294)

5mg/day

DRUGPlacebo

Placebo

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

FEMALE

Age

30 Years to 55 Years

Healthy volunteers

Inclusion criteria

* Patients with treatment-resistant menorrhagia scheduled for hysterectomy.

Exclusion criteria

* Organic causes of menorrhagia * Current hormone treatment

Design outcomes

Primary

Measure	Time frame
Individual relative change in uterine bleeding scores by PBAC	Pretreatment cycle treatment phase

Secondary

Measure	Time frame
Endometrial thickness	End of treatment
Adverse events collection	Whole treatment period
Bleeding pattern	Treatment period
Endometrial histology incl. immunohistochemical evaluations	End of treatment

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026