Clinical trial NCT00569244: SH T00186 in the Treatment of Primary Dysmenorrhea
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Primary Dysmenorrhea
Keywords: Primary Dysmenorrhea
Menstrual Pain
Oral Contraception
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2007-12-07
Enrollment: 223
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Number of days with dysmenorrheic pain
timeFrame: 140 days
Secondary outcomes:
measure: Use of rescue medication
timeFrame: 140 days
measure: Interference with daily activity
timeFrame: 140 days
measure: Number of days: with at least moderate dysmenorrheic pain
timeFrame: 140 days
measure: Number of days with pelvic pain
timeFrame: 140 days
measure: Number of days with dysmenorrheic pain associated with withdrawal bleeding
timeFrame: 140 days
measure: Number of days with dysmenorrheic pain associated with unscheduled bleeding
timeFrame: 140 days
measure: Bleeding patterns
timeFrame: Whole treatment period
measure: Assessment of treatment
timeFrame: Whole treatment period
Other outcomes:
Locations:
city: Heidelberg
country: Germany
state: Baden-Württemberg
city: Nürnberg
country: Germany
state: Bayern
city: Frankfurt
country: Germany
state: Hessen
city: Fulda
country: Germany
state: Hessen
city: Mühlheim
country: Germany
state: Hessen
city: Hannover
country: Germany
state: Niedersachsen
city: Hannover
country: Germany
state: Niedersachsen
city: Bernburg
country: Germany
state: Sachsen-Anhalt
city: Blankenburg
country: Germany
state: Sachsen-Anhalt
city: Burg
country: Germany
state: Sachsen-Anhalt
city: Jessen
country: Germany
state: Sachsen-Anhalt
city: Magdeburg
country: Germany
state: Sachsen-Anhalt
city: Magdeburg
country: Germany
state: Sachsen-Anhalt
city: Magdeburg
country: Germany
state: Sachsen-Anhalt
city: Leipzig
country: Germany
state: Sachsen
city: Leipzig
country: Germany
state: Sachsen
city: Leipzig
country: Germany
state: Sachsen
city: Wurzen
country: Germany
state: Sachsen
city: Gera
country: Germany
state: Thüringen
city: Kahla
country: Germany
state: Thüringen
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Berlin
country: Germany
city: Chesterfield
country: United Kingdom
state: Derbyshire
city: Newcastle Upon Tyne
country: United Kingdom
state: Tyne and Wear
city: London
country: United Kingdom
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References:
citation: 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.