Trial Condition(s):

Primary Dysmenorrhea

SH T00186 in the Treatment of Primary Dysmenorrhea

Bayer Identifier:

91587

ClinicalTrials.gov Identifier:

NCT00569244

EudraCT Number:

2006-004899-13

Study Completed

Trial 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.

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

Trial Summary

Enrollment Goal
223
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
EE20/DRSP (BAY86-5300)
Accepts Healthy Volunteers
No

Where to Participate

Loading...
Locations
Status
LocationsStatus
Locations

Universitätsklinikum Heidelberg

Heidelberg, Germany, 69120

Status
Completed
 
Locations

Praxis Hr. Dr. R. Kuett

Nürnberg, Germany, 90491

Status
Completed
 
Locations

Praxis Hr. Dr. Karl-Heinz Belling

Berlin, Germany, 13086

Status
Completed
 
Locations

Praxis Fr. Dr. B. Heuberger

Berlin, Germany, 12587

Status
Completed
 
Locations

Praxis Dr. Larbig

Fulda, Germany, 36037

Status
Completed
 
Locations

Praxis Fr. Dr. J. Tyagi

Mühlheim, Germany, 63165

Status
Completed
 
Locations

Praxis Fr. Dr. C. Burgkhardt

Leipzig, Germany, 04299

Status
Completed
 
Locations

Frauenarztpraxis Dr. Bernd Pittner

Leipzig, Germany, 04207

Status
Completed
 
Locations

Praxis Hr. Prof. Dr. H.-J. Ahrendt

Magdeburg, Germany, 39126

Status
Completed
 
Locations

Praxis Fr. A. Heweker

Bernburg, Germany, 06406

Status
Completed
 
Locations

Praxis Hr. H. Thelen

Jessen, Germany, 06917

Status
Completed
 
Locations

Frauenarztpraxis Dr. med. Gabriele Weinreich

Magdeburg, Germany, 39130

Status
Completed
 
Locations

Frauenarztpraxis Dr. Wetzel

Blankenburg, Germany, 38889

Status
Completed
 
Locations

Praxis Fr. Dr. A.Mönch-Hering

Kahla, Germany, 07768

Status
Completed
 
Locations

Praxis Hr. R. Wähnert

Gera, Germany, 07545

Status
Completed
 
Locations

Frauenarztpraxis Hr. Dr. H. Lindecke

Berlin, Germany, 10247

Status
Completed
 
Locations

Frauenarztpraxis Fr. Dr. Susanne Plettig

Berlin, Germany, 10409

Status
Completed
 
Locations

Praxis Dr. S. El Tobgui-Jensen

Frankfurt, Germany, 60439

Status
Completed
 
Locations

Praxis Hr. Dr. K. Greven

Hannover, Germany, 30459

Status
Completed
 
Locations

Praxis Fr. Dr. J. Schmidt-Pich

Hannover, Germany, 30159

Status
Completed
 
Locations

Praxis Fr. Dr. G. Förster

Leipzig, Germany, 04277

Status
Completed
 
Locations

Praxis Fr. I. Gröger

Wurzen, Germany, 04808

Status
Completed
 
Locations

Frauenarztpraxis Fr. Dr. Ulrike Krieg

Leipzig, Germany, 04207

Status
Completed
 
Locations

Praxis Fr. Dr. A. Braune

Magdeburg, Germany, 39104

Status
Completed
 
Locations

Frauenarztpraxis Hr. Dr. Bernd Hennig

Burg, Germany, 39288

Status
Completed
 
Locations

Frauenarztpraxis Dipl. med. Michael Stellmacher

Burg, Germany, 39288

Status
Completed
 
Locations

Newcastle General Hospital

Newcastle Upon Tyne, United Kingdom, NE4 5BE

Status
Completed
 
Locations

Queen Charlottes & Chelseas Hospital

London, United Kingdom, W12 0HS

Status
Completed
 
Locations

Avondale Surgery

Chesterfield, United Kingdom, S40 4TF

Status
Completed
 

Trial Design