Official Title: “A Multi-Center, Open-Label, Randomized, Controlled, Parallel-Group Study to Assess Efficacy and Safety of an Extended Flexible Regimen of the Combined Oral Contraceptive SH T00186D (0.02 mg Ethinylestradiol as Beta-Cyclodextrin Clathrate and 3 mg Drospirenone) Compared to the Conventional Regimen of SH T00186D in the Treatment of Primary Dysmenorrhea”

The investigational drug SH T00186D is an oral contraceptive. The investigational drug used in this study contains the estrogen ethinylestradiol (EE) and the progestogen drospirenone (DRSP).

The aim of the present study is to evaluate efficacy and safety of the investigational drug in the treatment of menstrual pain (pelvic pain occurring shortly before, at onset, during menstruation). Two different regimens of intake of the same investigational product will be compared.

Patients have to undergo 2 -3 Baseline cycles (depending on whether the patient was an OC user before), during which menstrual pain, bleeding events, and pain killer intake have to be documented. During this observation period, the intake of hormonal contraceptives is not allowed. Other contraceptive methods (condoms with spermicide, pessary with spermicide) have to be used. If the patient is eligible for the study, she will be randomly assigned to one of the two treatment groups. Treatment group A will take the medication according to an extended flexible regimen, i.e., tablet intake will be triggered by bleeding events. Treatment group B will take the study medication in the 24 + 4 days regimen. That means, tablets to be taken on cycle days

1 - 24 contain the hormone combination, whereas tablets 25 - 28 do not contain any active ingredients, i.e., these are so called placebo tablets.

Treatment will last at least 140 days, but can be prolonged in Treatment Group A depending of occurrence of menstrual bleeding. The overall study duration will be 10 months for each patient. During the whole study period, 5 visits are planned. At Screening and Final examination, a thorough physical examination and a gynecological examination (including breath palpation and cervical smear ) will be performed. Blood samples will be taken for safety laboratory parameters.

Additional examinations can be performed any time, if this becomes necessary for medical reasons.

Patients will be provided with a patient diary to document the intake of study medication, any bleeding events and days without bleeding, pregnancy test results, any dysmenorrheic (menstrual) pain and its intensity and its interference with daily activity, and intake of pain medication. The pain medication (ibuprofen) will be provided.

Study Type: Interventional

Study Design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study

Study Primary Completion Date: December 2009

Intervention(s) in this Clinical Trial

• Drug: YAZ flex (SH T00186D)
  • Extended flexible regimen of YAZ (SH T00186D); triggered by bleeding events(Tablet p.o. (oral))
• Drug: YAZ (SH T00186D)
  • YAZ (SH T 00186D) administered in the conventional regimen (24 days active + 4 days placebo) (Tablet p.o. (oral))

Arms, Groups and Cohorts in this Clinical Trial

• Experimental: Arm 1
• Active Comparator: Arm 2

Primary Measures

• Number of days with dysmenorrheic pain
  • Time Frame: 140 days
    Safety Issue?: No

Secondary Measures

• Use of rescue medication
  • Time Frame: 140 days
    Safety Issue?: No
• Interference with daily activity
  • Time Frame: 140 days
    Safety Issue?: No
• Number of days: with at least moderate dysmenorrheic pain;
  • Time Frame: 140 days
    Safety Issue?: No
• Number of days with pelvic pain
  • Time Frame: 140 days
    Safety Issue?: No
• Number of days with dysmenorrheic pain associated with withdrawal bleeding
  • Time Frame: 140 days
    Safety Issue?: No
• Number of days with dysmenorrheic pain associated with unscheduled bleeding
  • Time Frame: 140 days
    Safety Issue?: No
• Bleeding patterns
  • Time Frame: Whole treatment period
    Safety Issue?: Yes
• Assessment of treatment
  • Time Frame: Whole treatment period
    Safety Issue?: No

Inclusion Criteria:

• Otherwise healthy female patients with moderate to severe primary dysmenorrhea
• Prospective self-rated sum pain score of >/= 8 during the 2 baseline cycles
• Age between 18 and 40 years (inclusive) with smoking habits as follows:
• between 18 and 30 years of age. daily cigarette consumption not above 10
• above 30 years of age, no smoking

Exclusion Criteria:

• Current signs of history of any forms of secondary dysmenorrhea
• Any concomitant disease of condition that requires any intake of analgesic medication
• Occurrence of less than six menstrual cycles before Visit 1 following delivery, abortion, or lactation
• Clinically significant depression

Gender Eligibility for this Clinical Trial: Female

Minimum Age for this Clinical Trial: 18 Years

Maximum Age for this Clinical Trial: 40 Years

Are Healthy Volunteers Accepted for this Clinical Trial?: No

Lead Sponsor: Bayer

Overall Clinical Trial Officials and Contacts

Bayer Study Director Study Director Bayer  

Information obtained from ClinicalTrials.gov on July 02, 2009

Link to the current ClinicalTrials.gov record. http://clinicaltrials.gov/show/NCT00569244

Study ID Number: 91587

ClinicalTrials.gov Identifier: NCT00569244

Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Click here and search for drug information provided by the FDA

Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product

Click here to find results for studies related to marketed products