Effect on Primary Dysmenorrhea - NCT00909857-54601 (Clinical Trial 295674)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy295674.aspx
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| City: |
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La Crosse |
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State:
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WI |
| Zip Code: |
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54601 |
| Conditions: |
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Primary Dysmenorrhea |
| Purpose: |
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To investigate the potential benefits of a new oral contraceptive (SH T00658ID) on
alleviating complaints of dysmenorrhea associated with oral contraceptive use.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- Otherwise healthy female subjects requesting contraception and suffering from primary
dysmenorrhea with a sum score for dysmenorrheic pain3 intensity of >/= 8 over 2
baseline cycles documented by a prospective self-rated sum pain score
- Age: 14 - 50 years (inclusive; smokers must not be older than 30 years) at the time
point of informed consent
- Normal cervical smear not requiring further follow-up (a cervical smear has to be
taken at the screening visit, or a normal result has to be available that was
documented within the last 6 months before the screening visit)
- Women with cyclic menstrual bleeding, defined by a cycle length between 25 and 35
days and no amenorrheic cycles or cycles without withdrawal bleeding during the last
3 months prior to visit 1.
- Able to tolerate ibuprofen and willing to use only Ibuprofen supplied for the study.
Exclusion Criteria:
- Pregnancy or lactation (delivery, abortion, or lactation within three cycles before
the start of treatment)
- Obesity: body mass index (BMI) > 32 kg/m2
- Hypersensitivity to any of the study drug ingredients
- Any diseases or conditions that might interfere with the conduct of the study or the
interpretation of the results
- Presence or a history of venous or arterial thrombotic / thromboembolic events (e.g.
deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a
cerebrovascular accident, including prodromi (e.g. transient ischemic attack, angina
pectoris), and conditions that could increase the risk of suffering from any of the
above mentioned disorders, e.g. a family history indicating a hereditary
predisposition Undiagnosed abnormal genital bleeding
- Abuse of alcohol, drugs, or medicines (e.g. laxatives)
- Other contraceptive methods:
- Sterilization
- Oral, vaginal or transdermal hormonal contraception during treatment
- Intra-uterine devices (IUD) with or without hormone release still in place within 30
days of visit 1
- Simultaneous participation in another clinical trial or participation in another
clinical trial prior to study entry that might have an impact on the study objectives
at the discretion of the investigator
- Major surgery scheduled for the study period |
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| Study is available at: |
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La Crosse, WI 54601
United States
Primary Contact:
Bayer Clinical Trials Contact
Email: clinical-trials-contact@bayerhealthcare.com |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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March 16, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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