Clinical Trials Logo

Clinical Trial 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.


Clinical Trial Description

n/a


Study Design

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


Related Conditions & MeSH terms


NCT number NCT00569244
Study type Interventional
Source Bayer
Contact
Status Completed
Phase Phase 3
Start date December 2007
Completion date December 2009

See also
  Status Clinical Trial Phase
Completed NCT03594916 - Efficacy of Transcranial Direct Current Stimulation for Severe Primary Dysmenorrhea N/A
Completed NCT03608215 - Neuromodulatary Efficacy of Transcranial Direct Current Stimulation in Severe Refractory Primary Dysmenorrhea N/A
Not yet recruiting NCT04541134 - Phase 3 Clinical Trial to Evaluate of the Efficacy and Safety of DW9801 in Patients With Primary Dysmenorrhea Phase 3
Completed NCT04083131 - Sense of Coherence and Primary Dysmenorrhea in High School Girls in Finistere, France
Not yet recruiting NCT05448027 - Low Versus High Intensity Laser Therapy on Primary Dysmenorrhea N/A
Completed NCT04662814 - Extracorporeal Shock Wave Therapy for Dysmenorrhea N/A
Recruiting NCT05771753 - Comparison of Core Stabilization and Dynamic Stretching Exercises in Primary Dysmenorrhea N/A
Not yet recruiting NCT04665661 - Aerobic Exercise for Primary Dysmenorrhea N/A
Completed NCT03290066 - Effectiveness of Kinesiotaping in Primary Dysmenorrhea N/A
Completed NCT03593850 - Music for Pain in Primary Dysmenorrhea N/A
Completed NCT04235595 - Comparison of the Effects of TENS and CTM on Primary Dysmenorrhea N/A
Completed NCT05081869 - Investigation of the Effect of Online Yoga Based Exercise Program on Women With Primary Dysmenorrhea N/A
Not yet recruiting NCT06398990 - The Effect of Cognitive Exercise Therapy Approach and Yoga in Adolescents With Dysmenorrhoea N/A
Completed NCT02026206 - Low-level Light Therapy for Primary Dysmenorrhea Phase 3
Completed NCT05686460 - Effect of Hegu Point Ice Massage and Music in Dysmenorrhea N/A
Not yet recruiting NCT06052722 - The Relationship of Premenstrual Syndrome and Primary Dysmenorrhea With Severity of Temporomandibular Disorders N/A
Completed NCT04119011 - Probiotics in Women With Primary Dysmenorrhoea Phase 1/Phase 2
Active, not recruiting NCT05938660 - Effects of Acupressure at Sanyinjiao Point on Primary Dysmenorrhea Among University Students. N/A
Completed NCT04856280 - Kinesiological Taping and Aerobic Exercise in Women With Primary Dysmenorrhea: N/A
Completed NCT02602522 - Danshen-Jiang-Fu Granule Prepared by Danshen From Different Producing Areas for Primary Dysmenorrhea Early Phase 1