Efficacy and Safety Study for the Treatment of Dysfunctional Uterine Bleeding

Bayer

Status and phase: Completed; Phase 3

Conditions: Metrorrhagia

Treatments: Drug: Estradiol valerate/Dienogest (Natazia, Qlaira, BAY86-5027); Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00293059

308960 (Other Identifier)

91469

Details and patient eligibility

About

The purpose of this study is to determine whether the study drug is safe and effective in the treatment of dysfunctional uterine bleeding.

Full description

This study has previously been posted by Berlex, Inc. Berlex, Inc. has been renamed to Bayer HealthCare Pharmaceuticals, Inc.Bayer HealthCare Pharmaceuticals, Inc.is the sponsor of the trial.

Enrollment: 190 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women 18 years or older
• With diagnosis of dysfunctional uterine bleeding without organic pathology
• And with at least one of the following symptoms: prolonged, frequent, or excessive bleeding

Exclusion criteria

• The use of steroidal oral contraceptives, or any drug that could alter oral contraception metabolism will be prohibited during the study.
• Women with history of endometrial ablation or dilatation or curettage within 2 months prior to study start will be excluded.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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190 participants in 2 patient groups, including a placebo group

Estradiol valerate/Dienogest (Natazia, Qlaira, BAY86-5027)

Experimental group

Description:

A blister card consists of 28 pills taken orally once a day for 28 days (one cycle): 2 days of 3 mg estradiol valerate (EV); 5 days of 2 mg EV + 2 mg dienogest (DNG); 17 days of 2 mg EV + 3 mg DNG; 2 days of 1 mg EV; 2 days of placebo

Treatment:

Drug: Estradiol valerate/Dienogest (Natazia, Qlaira, BAY86-5027)

Placebo

Placebo Comparator group

Description:

Matching placebo to be taken orally daily

Treatment:

Drug: Placebo