Status:
COMPLETED
To Compare SH T00658ID Over Ortho Tri-Cyclen Lo (US/Canada)
Lead Sponsor:
Bayer
Conditions:
Contraception
Eligibility:
FEMALE
18-50 years
Phase:
PHASE3
Brief Summary
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 req...
Detailed Description
Safety issues are addressed in the Adverse Events section.
Eligibility Criteria
Inclusion
- 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)
- 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) Women with atypical squamous cell of undetermined significance (ASCUS) can be included if they have a negative human papilloma virus (HPV) test result. The laboratory will perform an HPV test if the Pap smear result is ASCUS.
- Able to tolerate ibuprofen and willing to use only ibuprofen supplied by the investigator
Exclusion
- 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
- Undiagnosed abnormal genital bleeding
- Abuse of alcohol, drugs, or medicines (eg, laxatives)
- Other contraceptive methods
- Any medication that could result in excessive accumulation, impaired metabolism, or altered excretion of the study drug or interfere with the conduct of the study or the interpretation of the results
- Simultaneous 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
- Subject is a dependent person, eg: a family member or member of the Investigator's staff
- Inability to cooperate with the study procedures for any reason, including language comprehension, psychiatric illness, inability to get to the study site
Key Trial Info
Start Date :
September 8 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
May 10 2011
Estimated Enrollment :
409 Patients enrolled
Trial Details
Trial ID
NCT00754065
Start Date
September 8 2008
End Date
May 10 2011
Last Update
November 20 2024
Active Locations (59)
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1
Independence, Arizona, United States, 94925
2
Phoenix, Arizona, United States, 85032
3
Encinitas, California, United States, 92024
4
San Diego, California, United States, 92108