Effect on Primary Dysmenorrhea

Bayer

Status and phase: Completed; Phase 3

Conditions: Primary Dysmenorrhea

Treatments: Drug: Placebo Match to SH T00658ID; Drug: Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027); Drug: Placebo Match to SH D593B; Drug: Ethinyl estradiol, Levonorgestrel (Miranova)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00909857

312042 (Other Identifier)

2008-005625-11 (EudraCT Number)

91781

Details and patient eligibility

About

To investigate the potential benefits of a new oral contraceptive (SH T00658ID) on alleviating complaints of dysmenorrhea associated with oral contraceptive use.

Enrollment: 507 patients

Sex: Female

Ages: 14 to 50 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Otherwise healthy female subjects requesting contraception and suffering from primary dysmenorrhea with a sum score for dysmenorrheic pain intensity of >/= 8 over 2 baseline cycles documented by a prospective self-rated sum pain score
• Age: 14 - 50 years (inclusive; smokers must not be older than 30 years) at the time point of informed consent
• Normal cervical smear not requiring further follow-up (a cervical smear has to be taken at the screening visit, or a normal result has to be available that was documented within the last 6 months before the screening visit)
• Women with cyclic menstrual bleeding, defined by a cycle length between 25 and 35 days and no amenorrheic cycles or cycles without withdrawal bleeding during the last 3 months prior to visit 1.
• Able to tolerate ibuprofen and willing to use only Ibuprofen supplied for the study.

Exclusion criteria

• Pregnancy or lactation (delivery, abortion, or lactation within three cycles before the start of treatment)

• Obesity: body mass index (BMI) > 32 kg/m2

• Hypersensitivity to any of the study drug ingredients

• Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results

• Presence or a history of venous or arterial thrombotic / thromboembolic events (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident, including prodromi (e.g. transient ischemic attack, angina pectoris), and conditions that could increase the risk of suffering from any of the above mentioned disorders, e.g. a family history indicating a hereditary predispositionUndiagnosed abnormal genital bleeding

• Abuse of alcohol, drugs, or medicines (e.g. laxatives)

• Other contraceptive methods:

  • Sterilization
  • Oral, vaginal or transdermal hormonal contraception during treatment
  • Intra-uterine devices (IUD) with or without hormone release still in place within 30 days of visit 1

• Simultaneous participation in another clinical trial or participation in another clinical trial prior to study entry that might have an impact on the study objectives at the discretion of the investigator

• Major surgery scheduled for the study period

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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507 participants in 2 patient groups

Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027)

Experimental group

Description:

Daily oral administration of one tablet SH T00658ID (BAY86-5027) plus one tablet placebo for 28 days without tablet-free interval for 3 treatment cycles

Treatment:

Drug: Placebo Match to SH T00658ID

Drug: Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027)

Ethinyl estradiol, Levonorgestrel (Miranova)

Active Comparator group

Description:

Daily oral administration of one tablet placebo plus one tablet SH D593B (Miranova) for 28 days without tablet-free interval for 3 treatment cycles

Treatment:

Drug: Placebo Match to SH D593B

Drug: Ethinyl estradiol, Levonorgestrel (Miranova)