SH T00186 in the Treatment of Primary Dysmenorrhea

NCT00569244 | Completed Phase 3

• 3 other identifiers: 915872006-004899-13310882
• Study Type: interventional
• Target: 223
• Locations: 2 countries
• Sites: 27

Brief Summary

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.

Conditions

Primary Dysmenorrhea

Keywords

Primary Dysmenorrhea; Menstrual Pain; Oral Contraception

Outcome Measures

Primary Outcomes (1)

• Number of days with dysmenorrheic pain

  140 days

Secondary Outcomes (8)

• Use of rescue medication

  140 days

• Interference with daily activity

  140 days

• Number of days: with at least moderate dysmenorrheic pain

  140 days

• Number of days with pelvic pain

  140 days

• Number of days with dysmenorrheic pain associated with withdrawal bleeding

  140 days

Study Arms (2)

Arm 1

EXPERIMENTAL

Drug: Drug: YAZ flex (SH T00186D)

Arm 2

ACTIVE COMPARATOR

Drug: YAZ (SH T00186D)

Interventions

Drug: YAZ flex (SH T00186D) DRUG

Extended flexible regimen of YAZ (SH T00186D); triggered by bleeding events(Tablet p.o. (oral))

Arm 1

YAZ (SH T00186D) DRUG

YAZ (SH T 00186D) administered in the conventional regimen (24 days active + 4 days placebo) (Tablet p.o. (oral))

Arm 2

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bayer: lead

Study Sites (27)

Unknown Facility

Heidelberg, Baden-Wurttemberg, 69120, Germany

Location

Unknown Facility

Nuremberg, Bavaria, 90491, Germany

Location

Unknown Facility

Frankfurt am Main, Hesse, 60439, Germany

Location

Unknown Facility

Fulda, Hesse, 36037, Germany

Location

Unknown Facility

Mühlheim am Main, Hesse, 63165, Germany

Location

Unknown Facility

Hanover, Lower Saxony, 30159, Germany

Location

Unknown Facility

Hanover, Lower Saxony, 30459, Germany

Location

Unknown Facility

Leipzig, Saxony, 04207, Germany

Location

Unknown Facility

Leipzig, Saxony, 04277, Germany

Location

Unknown Facility

Leipzig, Saxony, 04299, Germany

Location

Unknown Facility

Wurzen, Saxony, 04808, Germany

Location

Unknown Facility

Bernburg, Saxony-Anhalt, 06406, Germany

Location

Unknown Facility

Blankenburg, Saxony-Anhalt, 38889, Germany

Location

Unknown Facility

Burg, Saxony-Anhalt, 39288, Germany

Location

Unknown Facility

Jessen, Saxony-Anhalt, 06917, Germany

Location

Unknown Facility

Magdeburg, Saxony-Anhalt, 39104, Germany

Location

Unknown Facility

Magdeburg, Saxony-Anhalt, 39126, Germany

Location

Unknown Facility

Magdeburg, Saxony-Anhalt, 39130, Germany

Location

Unknown Facility

Berlin, State of Berlin, 10247, Germany

Location

Unknown Facility

Berlin, State of Berlin, 10409, Germany

Location

Unknown Facility

Berlin, State of Berlin, 12587, Germany

Location

Unknown Facility

Berlin, State of Berlin, 13086, Germany

Location

Unknown Facility

Gera, Thuringia, 07545, Germany

Location

Unknown Facility

Kahla, Thuringia, 07768, Germany

Location

Unknown Facility

Chesterfield, Derbyshire, S40 4TF, United Kingdom

Location

Unknown Facility

Newcastle upon Tyne, Tyne and Wear, NE4 5BE, United Kingdom

Location

Unknown Facility

London, W12 0HS, United Kingdom

Location

Related Publications (2)

• Strowitzki T, Kirsch B, Elliesen J. Efficacy of ethinylestradiol 20 mug/drospirenone 3 mg in a flexible extended regimen in women with moderate-to-severe primary dysmenorrhoea: an open-label, multicentre, randomised, controlled study. J Fam Plann Reprod Health Care. 2012 Apr;38(2):94-101. doi: 10.1136/jfprhc-2011-100225.

  PMID: 22454006 RESULT

• Schroll JB, Black AY, Farquhar C, Chen I. Combined oral contraceptive pill for primary dysmenorrhoea. Cochrane Database Syst Rev. 2023 Jul 31;7(7):CD002120. doi: 10.1002/14651858.CD002120.pub4.

  PMID: 37523477 DERIVED

Related Links

• Click here and search for information of Bayer products for Europe

MeSH Terms

Conditions

Dysmenorrhea

Interventions

drospirenone and ethinyl estradiol combination

Condition Hierarchy (Ancestors)

Menstruation Disturbances; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pelvic Pain; Pain; Neurologic Manifestations; Signs and Symptoms

Study Officials

• Bayer Study Director

  Bayer

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2007
• First Posted: December 7, 2007
• Study Start: December 1, 2007
• Primary Completion: December 1, 2009
• Study Completion: December 1, 2009
• Last Updated: October 29, 2014

Record last verified: 2014-10

Locations

GB (3); DE (24)