Primary Dysmenorrhea Clinical Trial
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
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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