Study of a 4-phasic Oral Contraceptive for the Treatment of Heavy Menstrual Bleeding

• Status: Completed
• Trial end date: 2015-06-01
• Target enrollment: 0
• Participant gender: Female

Summary

To evaluate efficacy and safety of a combined oral contraceptive of estradiol valerate and dienogest in the treatment of heavy menstrual bleeding

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Bayer
• Treatments: Contraceptive Agents; Contraceptives, Oral; Dienogest; Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Polyestradiol phosphate

Criteria

Inclusion Criteria:

• Women 18 years or older in generally good health with a diagnosis of heavy menstrual bleeding without organic pathology, requesting contraception

• Willingness to use barrier contraception (e.g., condoms) from screening to study completion

• Willingness to use and collect sanitary protection (pads and tampons) provided by the sponsor and compatible with the alkaline hematin test throughout study completion

Exclusion Criteria:

• Current diagnosis of organic uterine bleeding

• History of endometrial ablation, or dilatation and curettage within 2 months of Visit 1.

• Clinically significant pelvic findings (whether or not confirmed by transvaginal ultrasound [TVU]).

• Clinically significant abnormal results of breast examination (breast palpation).

• Positive pregnancy test at Visit 1

• Less than three months since delivery, abortion, or lactation before to start Visit 1

• Other contraceptive methods

• Any disease or condition that may worsen under hormonal treatment

• Smokers over the age of 35

• Body mass index >32