SH T00186 in the Treatment of Primary Dysmenorrhea

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT00569244
First received: December 5, 2007
Last updated: October 28, 2014
Last verified: October 2014
  Purpose

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.


Condition Intervention Phase
Primary Dysmenorrhea
Drug: Drug: YAZ flex (SH T00186D)
Drug: YAZ (SH T00186D)
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
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

Resource links provided by NLM:


Further study details as provided by Bayer:

Primary Outcome Measures:
  • Number of days with dysmenorrheic pain [ Time Frame: 140 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Use of rescue medication [ Time Frame: 140 days ] [ Designated as safety issue: No ]
  • Interference with daily activity [ Time Frame: 140 days ] [ Designated as safety issue: No ]
  • Number of days: with at least moderate dysmenorrheic pain [ Time Frame: 140 days ] [ Designated as safety issue: No ]
  • Number of days with pelvic pain [ Time Frame: 140 days ] [ Designated as safety issue: No ]
  • Number of days with dysmenorrheic pain associated with withdrawal bleeding [ Time Frame: 140 days ] [ Designated as safety issue: No ]
  • Number of days with dysmenorrheic pain associated with unscheduled bleeding [ Time Frame: 140 days ] [ Designated as safety issue: No ]
  • Bleeding patterns [ Time Frame: Whole treatment period ] [ Designated as safety issue: Yes ]
  • Assessment of treatment [ Time Frame: Whole treatment period ] [ Designated as safety issue: No ]

Enrollment: 223
Study Start Date: December 2007
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Drug: YAZ flex (SH T00186D)
Extended flexible regimen of YAZ (SH T00186D); triggered by bleeding events(Tablet p.o. (oral))
Active Comparator: Arm 2 Drug: YAZ (SH T00186D)
YAZ (SH T 00186D) administered in the conventional regimen (24 days active + 4 days placebo) (Tablet p.o. (oral))

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00569244

Locations
Germany
Heidelberg, Baden-Württemberg, Germany, 69120
Nürnberg, Bayern, Germany, 90491
Frankfurt, Hessen, Germany, 60439
Fulda, Hessen, Germany, 36037
Mühlheim, Hessen, Germany, 63165
Hannover, Niedersachsen, Germany, 30459
Hannover, Niedersachsen, Germany, 30159
Bernburg, Sachsen-Anhalt, Germany, 06406
Blankenburg, Sachsen-Anhalt, Germany, 38889
Burg, Sachsen-Anhalt, Germany, 39288
Jessen, Sachsen-Anhalt, Germany, 06917
Magdeburg, Sachsen-Anhalt, Germany, 39104
Magdeburg, Sachsen-Anhalt, Germany, 39126
Magdeburg, Sachsen-Anhalt, Germany, 39130
Leipzig, Sachsen, Germany, 04207
Leipzig, Sachsen, Germany, 04299
Leipzig, Sachsen, Germany, 04277
Wurzen, Sachsen, Germany, 04808
Gera, Thüringen, Germany, 07545
Kahla, Thüringen, Germany, 07768
Berlin, Germany, 10247
Berlin, Germany, 13086
Berlin, Germany, 10409
Berlin, Germany, 12587
United Kingdom
Chesterfield, Derbyshire, United Kingdom, S40 4TF
Newcastle Upon Tyne, Tyne and Wear, United Kingdom, NE4 5BE
London, United Kingdom, W12 0HS
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Publications:
Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT00569244     History of Changes
Other Study ID Numbers: 91587, 2006-004899-13, 310882
Study First Received: December 5, 2007
Last Updated: October 28, 2014
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Bayer:
Primary Dysmenorrhea
Menstrual Pain
Oral Contraception

Additional relevant MeSH terms:
Dysmenorrhea
Menstruation Disturbances
Pain
Pathologic Processes
Pelvic Pain
Signs and Symptoms
Contraceptives, Oral, Combined
Contraceptive Agents
Contraceptive Agents, Female
Contraceptives, Oral
Pharmacologic Actions
Physiological Effects of Drugs
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014