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

A Multicenter, Double-blind, Randomized, Parallel-group, Placebo-controlled, 7 Cycle Duration (196 Days), Phase 3 Study to Investigate the Efficacy and Safety of Oral Estradiol Valerate / Dienogest Tablets for the Treatment of Heavy Menstrual Bleeding

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

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