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View Clinical Trial (Medical Research Study)
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To Compare SH T00658ID to Ortho Tri-Cyclen Lo (US/Canada) - NCT00754065-33759 (Clinical Trial 242220)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy242220.aspx
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| City: |
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Clearwater |
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State:
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FL |
| Zip Code: |
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33759 |
| Conditions: |
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Oral Contraceptive |
| Purpose: |
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The objective of the study is to compare the oral contraceptive (OC) SH T00658ID over Ortho
Tri-Cyclen Lo administered for 13 cycles to healthy female volunteers between 18 and 50
years of age who request oral contraceptive protection. Subjects on a LNG, NGM, or
norethindrone/norethindrone acetate containing oral contraceptive in a 21-day regimen
suffering from hormone withdrawal-associated symptoms such of pelvic pain or headache or
both, and willing to continue OC use but to switch to SH T00658ID or Ortho Tri-Cyclen Lo.
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| Study summary: |
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| Criteria: |
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Inclusion Criteria:
- Signed and dated informed consent
- Age between 18 and 50 years (inclusive), smokers maximum age of 35 years (inclusive)
at Visit 1
- Otherwise healthy female subjects requesting contraception and currently using a LNG,
NGM, or norethindrone/norethindrone acetate containing OC in a 21-day regimen and
suffering from at least moderate pelvic pain, headache or both defined by an average
of the highest 3 values of >/=35 mm on a VAS during cycle days 22-28 (35 mm VAS is
the expected standard deviation of the population VAS reduction [Section 11.3]
- Normal or clinically insignificant cervical smear not requiring further follow up (a
cervical smear has to be taken at screening visit or a normal result has to be
documented within the last 6 months before screening)
- Able to tolerate ibuprofen and willing to use only ibuprofen supplied by the
investigator
Exclusion Criteria:
- Pregnancy or lactation (less than three cycles since delivery, abortion, or lactation
before start of treatment)
- Body mass index (BMI) >32 kg/m2
- Hypersensitivity to any of the study drug ingredients
- Individuals not willing to consume pork and beef products. Women may be included if
they are willing to take the capsules
- Safety relevant laboratory values, provided by the central laboratory, outside
inclusion range before start of treatment
- Any diseases or conditions that can compromise the function of the body systems and
could result in altered absorption, excessive accumulation, impaired metabolism, or
altered excretion of the study medication (such as but not limited to duodenal
ulcers, gastritis, gastrectomy or gastric resection surgery, or renal compromise)
- Any diseases or conditions that might interfere with the conduct of the study or the
interpretation of the results
- Any disease or condition that may worsen under hormonal treatment |
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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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October 10, 2009 |
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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