Efficacy and Safety Study for the Treatment of Dysfunctional Uterine Bleeding

Bayer

Status and phase: Completed; Phase 3

Conditions: Metrorrhagia

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

Study type: Interventional

Funder types: Industry

Identifiers

NCT00307801

91470

2005-004340-32 (EudraCT Number)

308961 (Other Identifier)

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

The study has previously been posted by Schering AG, Germany. Schering AG, Germany has been renamed to Bayer HealthCare AG, Germany. Bayer HealthCare AG, Germany is the sponsor of the trial.

Enrollment: 231 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Women 18 years or older
• And with a 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 a history of endometrial ablation or dilatation and 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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231 participants in 2 patient groups, including a placebo group

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

Experimental group

Description:

A blister consists of 28 tablets 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