To Compare SH T00658ID Over Ortho Tri-Cyclen Lo (US/Canada)

• Status: Completed
• Trial end date: 2011-05-01
• Target enrollment: 0
• Participant gender: Female

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 request oral contraceptive protection. Subjects on a levonorgestrel (LNG), norgestimate (NGM), norethindrone or norethindrone acetate containing oral contraceptive in a 21-day regimen suffering from hormone withdrawal-associated symptoms such as pelvic pain or headache or both, and willing to continue OC use but to switch to SH T00658ID or Ortho Tri-Cyclen Lo.

• Phase: Phase 3
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Bayer
• Treatments: Contraceptive Agents; Contraceptives, Oral; Dienogest; Estradiol; Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Estradiol valerate; Ethinyl Estradiol; Fluoroquinolones; Moxifloxacin; Nandrolone; Norgestimate, ethinyl estradiol drug combination; Polyestradiol phosphate

Criteria

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)

• 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 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

• 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