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

Bayer

Status and phase: Completed; Phase 3

Conditions: Contraception

Treatments: Drug: Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027); Drug: Ortho Tri Cyclen Lo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00754065

13108

Details and patient eligibility

About

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.

Full description

Safety issues are addressed in the Adverse Events section.

Enrollment: 409 patients

Sex: Female

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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409 participants in 2 patient groups

Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027)

Experimental group

Description:

Daily oral administration of one capsule BAY86-5027 \[estradiol valerate (EV) / dienogest (DNG)\] for 26 days, followed by one capsule placebo for 2 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)

Treatment:

Drug: Estradiol valerate, Dienogest (Natazia, Qlaira, BAY86-5027)

Ortho Tri-Cyclen Lo

Active Comparator group

Description:

Daily oral administration of one capsule Ortho Tri-Cyclen Lo \[Ethinylestradiol (EE)/ Norgestimate (NGM)\] for 21 days, followed by one capsule placebo for 7 days (28 days total per cycle) for 13 treatment cycles (treatment encapsulated)

Treatment:

Drug: Ortho Tri Cyclen Lo