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

Bayer

Status and phase: Completed; Phase 3

Conditions: Metrorrhagia

Treatments: Drug: EV/DNG (Qlaira, Natazia, BAY86-5027); Drug: placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT01638923

X311965 (Other Identifier)

91774

Details and patient eligibility

About

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

Enrollment: 339 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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339 participants in 2 patient groups, including a placebo group

Arm 1

Experimental group

Treatment:

Drug: EV/DNG (Qlaira, Natazia, BAY86-5027)

Arm 2

Placebo Comparator group

Treatment:

Drug: placebo