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

• Proportion of subjects with successful treatment [ Time Frame: 90 days during treatment phase ] [ Designated as safety issue: No ]
  Successful treatment is definded as no bleeding episode with MBL of 80 mL or more and a decrease to a value </=50% of MBL compared to 90 day run-in period
• Percent change of MBL at baseline and 90 day period during treatment phase [ Time Frame: Baseline and 90 days during treatment phase ] [ Designated as safety issue: No ]
• Absolute change of average MBL at baseline and up to cycle 7 (one cycle = 28 days) [ Time Frame: Baseline and cycle 1, cycle 2, cycle 3, cycle 4, cycle 5, cycle 6, cycle 7 ] [ Designated as safety issue: No ]
• Proportion of subjects with improvement in the investigator's global assessment scale on Day 84 [ Time Frame: Treatment day 84 ] [ Designated as safety issue: No ]
  Investigator's global assessment scale: 0 = not assessed; 1 = very much improved; 2 = much improved; 3 = improved; 4 = no change; 5 = worse; 6 = much worse; 7 = very much worse; Improvement is defined as the assessment score = 1, 2, or 3.
• Proportion of subjects with improvement in the investigator's global assessment scale on Day 196 [ Time Frame: Treatment day 196 ] [ Designated as safety issue: No ]
  Investigator's global assessment scale: 0 = not assessed; 1 = very much improved; 2 = much improved; 3 = improved; 4 = no change; 5 = worse; 6 = much worse; 7 = very much worse; Improvement is defined as the assessment score = 1, 2, or 3.
• Proportion of subjects with improvement in the subject's global assessment scale on Day 84 [ Time Frame: Treatment day 84 ] [ Designated as safety issue: No ]
  Subject's global assessment scale: 0 = not assessed; 1 = very much improved; 2 = much improved; 3 = improved; 4 = no change; 5 = worse; 6 = much worse; 7 = very much worse; Improvement is defined as the assessment score = 1, 2, or 3.
• Proportion of subjects with improvement in the subject's global assessment scale on Day 196 [ Time Frame: Treatment day 196 ] [ Designated as safety issue: No ]
  Subject's global assessment scale: 0 = not assessed; 1 = very much improved; 2 = much improved; 3 = improved; 4 = no change; 5 = worse; 6 = much worse; 7 = very much worse; Improvement is defined as the assessment score = 1, 2, or 3.
• Number of participants with adverse events as a measure of safety and tolerability [ Time Frame: Up to 12 months ] [ Designated as safety issue: Yes ]

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

• Drug: EV/DNG (Qlaira, Natazia, BAY86-5027)
  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. A blister card consists of 28 pills, taken orally once a day for 7 cycles of 28 days each.
• Drug: placebo
  Matching placebo to be taken orally daily for 7 cycles of 28 days each.

• Experimental: Arm 1
  Intervention: Drug: EV/DNG (Qlaira, Natazia, BAY86-5027)
• Placebo Comparator: Arm 2
  Intervention: Drug: placebo

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 abnormal transvaginal ultrasound results.
• 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