SH T00186 in the Treatment of Primary Dysmenorrhea

Condition(s) targeted: Primary Dysmenorrhea

Intervention: YAZ flex (SH T00186D) (Drug); YAZ (SH T00186D) (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Bayer

Official(s) and/or principal investigator(s):
Bayer Study Director, Study Director, Affiliation: Bayer

Overall contact:
Bayer Clinical Trial Contact, Email: clinical-trials-contact@bayerhealthcare.com

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.

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

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

Primary outcome: Number of days with dysmenorrheic pain

Secondary outcome:

Use of rescue medication

Interference with daily activity

Number of days: with at least moderate dysmenorrheic pain;

Number of days with pelvic pain

Number of days with dysmenorrheic pain associated with withdrawal bleeding

Number of days with dysmenorrheic pain associated with unscheduled bleeding

Bleeding patterns

Assessment of treatment

Minimum age: 18 Years. Maximum age: 40 Years. Gender(s): Female.

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

Bayer Clinical Trial Contact, Email: clinical-trials-contact@bayerhealthcare.com

Berlin 13086, Germany; Active, not recruiting

Berlin 12587, Germany; Active, not recruiting

Berlin 10247, Germany; Active, not recruiting

Berlin 10409, Germany; Active, not recruiting

London W12 0HS, United Kingdom; Recruiting

Heidelberg, Baden-Württemberg 69112, Germany; Active, not recruiting

Nürnberg, Bayern 90491, Germany; Completed

Chesterfield, Derbyshire S40 4TF, United Kingdom; Recruiting

Frankfurt, Hessen 60439, Germany; Active, not recruiting

Fulda, Hessen 36037, Germany; Active, not recruiting

Mühlheim, Hessen 63165, Germany; Active, not recruiting

Hannover, Niedersachsen 30459, Germany; Completed

Hannover, Niedersachsen 30159, Germany; Completed

Leipzig, Sachsen 04299, Germany; Active, not recruiting

Leipzig, Sachsen 04277, Germany; Active, not recruiting

Wurzen, Sachsen 04808, Germany; Active, not recruiting

Leipzig, Sachsen 04207, Germany; Active, not recruiting

Magdeburg, Sachsen-Anhalt 39126, Germany; Active, not recruiting

Magdeburg, Sachsen-Anhalt 39104, Germany; Active, not recruiting

Burg, Sachsen-Anhalt 39288, Germany; Active, not recruiting

Bernburg, Sachsen-Anhalt 06406, Germany; Active, not recruiting

Jessen, Sachsen-Anhalt 06917, Germany; Active, not recruiting

Magdeburg, Sachsen-Anhalt 39130, Germany; Active, not recruiting

Blankenburg, Sachsen-Anhalt 38889, Germany; Active, not recruiting

Kahla, Thüringen 07768, Germany; Active, not recruiting

Gera, Thüringen 07545, Germany; Active, not recruiting

Newcastle Upon Tyne, Tyne and Wear NE4 5BE, United Kingdom; Not yet recruiting

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Starting date: December 2007
Ending date: December 2009
Last updated: January 9, 2009