A multicenter, open, randomized, parallel-group comparison to assess the safety and efficacy of the oral contraceptive SH T 00186 D (0.02 mg ethinylestradiol as betadex clathrate and 3 mg drospirenone) in two variations of an extended regimen vs. a standard regimen (24 + 4 days) in 1122 healthy female volunteers for one year, followed by a 1-year safety extensio
- Conditions
- healthy volunteers requesting oral contraception
- Registration Number
- EUCTR2005-002125-32-DE
- Lead Sponsor
- Bayer Schering Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 1122
General inclusion criteria
- Signed and dated informed consent
- Healthy volunteer requesting contraception
- Age between 18 and 35 years (inclusive), smokers maximum age of 30 years
(inclusive) at screening
- Non-suspicious (normal) cervical smear taken at visit 1 or within the last 6 months
prior to visit 1 (provided a corresponding report is available)
Additional inclusion criteria subgroups
- Mean ‘pretreatment’ BMD T-score > -1 at the lumbar spine (L1-L4) (for subgroup
1 ‘bone mineral density’)
- Wash-out period of 2 months if sex hormones were used prior to start of study
medication (for subgroup 1 and 2 ‘metabolic parameters, hormones, biopsies’)
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
General and gynecological exclusion criteria
- Pregnancy, lactation (at least three cycles have to follow delivery, abortion, or
lactation before start of treatment)
- Body mass index (BMI) < 18 and > 30
- Hypersensitivity to any of the study drug ingredients
- Any disease or condition 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
- Any disease that may worsen under hormonal treatment or might interfere with
the conduct of the study or the interpretation of the results (e.g., herpes
gestationis or idiopathic icterus during a previous pregnancy; middle-ear deafness
(otosclerosis), Sydenham chorea, porphyria, disturbances in bile flow (presence or
history of cholestasis, gallstones), systemic lupus erythematodes)
- Diagnosed or suspected malignant or premalignant disease
- Liver diseases: presence or history of severe hepatic diseases including benign or
malignant tumors. There should be an interval of at least 3 months between the
start of study medication intake and the return of liver function values to normal.
- Vascular diseases and coagulation disorders: Presence or history of venous
thromboembolic diseases (deep vein thrombosis, pulmonary embolism), presence
or history of arterial thromboembolic diseases (e.g., myocardial infarction, stroke),
and any condition which could increase the risk to suffer from any of the above
mentioned disorders, e.g., a positive family history (event that occurred in a
sibling or a parent at an early age) or a suspected hereditary predisposition.
- Other diseases: chronic inflammatory bowel disease (Crohn's disease or
ulcerative colitis), hemolytic uremic syndrome, migraine with focal neurologic
symptoms (complicated migraine)
- Undiagnosed vaginal bleeding
- Uncontrolled thyroid disorders
- Dyslipoproteinaemia
- Pancreatitis or a history thereof if associated with severe hypertriglyceridaemia
(fasting triglycerides = 200mg/dl; fasting total cholesterol = 260mg/dl)
- Uncontrolled arterial hypertension (confirmed systolic blood pressure > 140 mmHg
or confirmed diastolic blood pressure > 90 mmHg)
- Diabetes mellitus with vascular involvement
- Sickle-cell anemia
- Current or history of clinically significant depression
- Current or history of alcohol or drug abuse
- Prohibited concomitant medication (as listed in protocol)
- Laboratory test results with clinically relevant abnormalities
- Intake of an experimental drug within 1 month prior to inclusion in the study (visit
1)
- Other contraceptive methods such as sterilization or use of intrauterine devices
(IUDs)
- Less than six cycles following i.m. depot contraception, less than one cycle
following the removal of hormone-containing implants or intrauterine devices with
or without hormone release (visit 2)
- Volunteers who previously discontinued the use of oral contraceptives due to
intracyclic bleeding episodes
- Volunteer is a dependant person, e.g., a relative / family member, a member of
the investigator’s staff, and / or is a student of the investigational site
Additional exclusion criteria for subgroup 1 ’bone mineral density‘
- BMI < 20 and > 30
- Inactivity or bed rest longer than three weeks within the past 12 months
- Excessive physical training
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method