Safety Study of Ethinylestradiol/Drospirenone in Dysmenorrhea

Bayer

Status and phase: Completed; Phase 3; Phase 2

Conditions: Dysmenorrhea

Treatments: Drug: DRSP 3 mg/EE 20 µg (13 cycles); Drug: DRSP 3 mg/EE 30 µg (6 cycles)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00461305

91616

310284 (Other Identifier)

Details and patient eligibility

About

The purpose of this study is to investigate efficacy of ethinylestradiol for intracyclic bleeding profile in patients with dysmenorrhea and to investigate the long term safety

Full description

The "drospirenone 3 mg/ethinylestradiol 20 μg (13 cycles)" group is to be treated by oral administration for 52 weeks, 13 cycles. The "drospirenone 3 mg/ethinylestradiol 30 μg (6 cycles)" group is to be treated by oral administration for 24 weeks, 6 cycles.

The trial is sponsored by Bayer Yakuhin, Ltd.

Enrollment: 420 patients

Sex: Female

Ages: 20+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Patients aged 20 years or older at obtaining informed consent
• Patients having the normal menstrual cycle (25 to 38 days) in the latest two menses before the final enrollment
• Patients having a total dysmenorrheal score of at least 3 points in twice of the latest menstruation before the final enrollment

Exclusion criteria

• Patients with ovarian chocolate cysts
• Patients with fibroid needed to be treated
• Patients with estrogen-dependent tumors and patients with cervical cancer or suspected cervical cancer
• Patients with undiagnosed abnormal vaginal bleeding
• Patients with thrombophlebitis, pulmonary embolism, cerebrovascular disease, or coronary artery disease or a history of those diseases
• Patients aged 35 years or older who smoke at least 15 cigarettes per day
• Patients with migraine accompanied by prodromata
• Patients with pulmonary hypertension or valvular heart disease
• Patients who are regularly taking nutritional products that contain St. John's Wort
• Patients who underwent surgical treatment for endometriosis within 2 months prior to screening
• Patients who may need to regularly use analgesics for therapeutic objectives other than relief from the pain of dysmenorrhea during this study (occasional use permitted)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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420 participants in 2 patient groups

DRSP 3 mg/EE 20 µg (13 cycles)

Experimental group

Description:

1 tablet per day Drospirenone (DRSP) 3 mg/Ethinylestradiol (EE) 20 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 52 weeks (13 cycles)

Treatment:

Drug: DRSP 3 mg/EE 20 µg (13 cycles)

DRSP 3 mg/EE 30 µg (6 cycles)

Experimental group

Description:

1 tablet per day Drospirenone 3 mg/Ethinylestradiol 30 µg for 24 days and 1 tablet per day placebo for 4 days in each 28-day cycle; treatment duration 24 weeks (6 cycles)

Treatment:

Drug: DRSP 3 mg/EE 30 µg (6 cycles)