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

Sponsor:	Bayer
Information provided by:	Bayer
ClinicalTrials.gov Identifier:	NCT00754065

Purpose

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, 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.

Condition	Intervention	Phase
Contraception	Drug: Qlaira (BAY86-5027, SH T00658ID) Drug: Ortho Tri Cyclen Lo	Phase 3

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator) Primary Purpose: Treatment
Official Title:	A Multicenter, Randomized, Double-blind, Active-controlled, Parallel Group, 2-arm Study to Show Superiority of the Oral Contraceptive SH T00658ID Over Ortho Tri-Cyclen Lo on Hormone Withdrawal-associated Symptoms After 6 Cycles of Treatment.

Resource links provided by NLM:

MedlinePlus related topics: Birth Control Headache Nausea and Vomiting Pelvic Pain

Drug Information available for: Estradiol Moxifloxacin Moxifloxacin hydrochloride

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:

The change of pelvic pain (stratum 1) or the change of headache (stratum 2) as determined by the change of average VAS (Visual Analog Scale) during cycle days 22 to 28 [ Time Frame: From Baseline to Cycle 6. ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Change in the highest three VAS of the hormone withdrawal-associated symptoms pelvic pain or headache [ Time Frame: during cycle days 22 to 28 from Baseline to Cycle 3 and Baseline to Cycle 13 ] [ Designated as safety issue: No ]
Rescue medication consumption [ Time Frame: Baseline to Cycle 6 and Baseline to Cycle 13 ] [ Designated as safety issue: No ]
Frequency and intensity of other hormone-related symptoms (bloating or swelling, breast tenderness, and nausea or vomiting) [ Time Frame: during cycle days 22 to 28, Baseline to Cycle 6 and Baseline to Cycle 13 ] [ Designated as safety issue: No ]
Prevalence of individual hormone-related symptoms [ Time Frame: during cycle days 1 to 21, Baseline to Cycle 6 and Baseline to Cycle 13 ] [ Designated as safety issue: No ]
Prevalence of individual hormone-related symptoms during hormone-free interval [ Time Frame: cycle days 27+28 for EV/DNG capsules and cycle days 22 to 28 for the comparator ] [ Designated as safety issue: No ]
Bleeding pattern and cycle control [ Time Frame: Baseline to Cycle 13 ] [ Designated as safety issue: No ]
Quality of Life Questionnaires [ Time Frame: Baseline to Cycle 13 ] [ Designated as safety issue: No ]
Clinical Global Impression scale [ Time Frame: Baseline to Cycle 13 ] [ Designated as safety issue: No ]

Enrollment:	409
Study Start Date:	September 2008
Study Completion Date:	May 2011
Primary Completion Date:	May 2011 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: Arm 1	Drug: Qlaira (BAY86-5027, SH T00658ID) EV/DNG
Active Comparator: Arm 2	Drug: Ortho Tri Cyclen Lo Ortho Tri Cyclen Lo

Eligibility

Ages Eligible for Study:	18 Years to 50 Years
Genders Eligible for Study:	Female
Accepts Healthy Volunteers:	Yes

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 ASCUS can be included if they have a negative 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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00754065

Show 59 Study Locations

Sponsors and Collaborators

Bayer

Investigators

Study Director:

Bayer Study Director

Bayer

More Information

Additional Information:

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No publications provided

Responsible Party:	Therapeutic Area Head, Bayer HealthCare Pharmaceuticals Inc.
ClinicalTrials.gov Identifier:	NCT00754065 History of Changes
Other Study ID Numbers:	13108
Study First Received:	September 16, 2008
Last Updated:	July 6, 2011
Health Authority:	Canada: Health Canada United States: Food and Drug Administration

Keywords provided by Bayer:

Oral contraceptive
Estradiol valerate and dienogest
EV/DNG
comparative tolerability

Additional relevant MeSH terms:

Contraceptive Agents
Norgestimate, ethinyl estradiol drug combination
Contraceptives, Oral
Moxifloxacin
Reproductive Control Agents
Physiological Effects of Drugs

Pharmacologic Actions
Therapeutic Uses
Contraceptive Agents, Female
Anti-Infective Agents
Contraceptives, Oral, Combined

ClinicalTrials.gov processed this record on May 24, 2012