Study Completed

Premenstrual Syndrome, Contraceptives, Oral

Bayer Identifier:

91001

ClinicalTrials.gov Identifier:

Not Available

EudraCT Number:

Not Available

EU CT Number:

Not Available

Study to assess efficacy of a monophasic oral contraceptive preparation containing Drospirenone 3 mg/Ethinylestradiol 20 μg in the treatment of Premenstrual Dysphonic Disorder

Trial purpose

Please see attached Study Results Summary below.

Key Participants Requirements

Sex

N/A

Age

N/A

Trial summary

Enrollment Goal

Trial Dates

January 2002 - September 2003

Phase

Phase 3

Could I Receive a placebo

N/A

Products

YAZ (EE20/DRSP, BAY86-5300)

Accepts Healthy Volunteer

N/A

Primary Outcome

Secondary Outcome

Trial design

A Multicenter, Double-Blind, Randomized, Placebo-Controlled, Crossover Study to Evaluate the Efficacy of a Monophasic Oral Contraceptive Preparation, Containing Drospirenone 3 mg/Ethinyl Estradiol 20 μg (as Beta-Cyclodextrin Clathrate), in the treatment of Premenstrual Dysphoric Disorder (PMDD)

Trial Type

Interventional

Intervention Type

N/A

Trial Purpose

N/A

Allocation

N/A

Blinding

N/A

Assignment

N/A

Trial Arms

N/A

Additional Information

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