A multi-center, double-blind, randomized, parallel-group study to evaluate cycle control and safety of 6 different regimens of an oral contraceptive containing estradiol and drospirenone in healthy female volunteers aged between 18 and 35 years over 7 cycles
- Conditions
- The trial will be performed in healthy female volunteers. The intended indication is female contraception.
- Registration Number
- EUCTR2007-005258-22-DE
- Lead Sponsor
- Bayer Schering Pharma AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- Not specified
Signed and dated informed consent
Healthy female volunteers
Age: 18 – 35 years (inclusive), smokers must not be older than 30 years at inclusion
History of regular cyclic menstrual periods (with a cycle length between 25 and 35 days)
Willingness to use barrier methods of contraception (condoms with spermicide, diaphragms with spermicide, spermicidal vaginal suppositories) or abstinence during the trial.
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)
F.1.3.1 Number of subjects for this age range
1. Pregnancy, lactation (less than three menstrual cycles before Visit 1 following delivery, abortion, or lactation)
2. Obesity (BMI > 30.0 kg/m2)
3. Hypersensitivity to active substances or to any of the excipients
4. Abnormal, suspicious or unclear cervical smear (a cervical smear has to be taken at Visit 1 or a normal result has to be documented within the last 6 months before Visit1)
5. Laboratory values outside inclusion range at Screening
6. 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
7. Any disease that may worsen under hormonal treatment or might interfere with the conduct of the study or the interpretation of the results, as e.g.:
Cardiovascular:
-presence or a history of venous or arterial thrombotic / thromboembolic events (e.g. deep venous thrombosis, pulmonary embolism, myocardial infarction) or of a cerebrovascular accident, including prodromi (e.g. transient ischemic attack, angina pectoris) and conditions which could increase the risk to suffer from any of the above mentioned disorders, e.g. a family history indicating a hereditary predisposition.
-uncontrolled arterial hypertension (repeated measurements of systolic blood pressure > 140 mmHg and/or diastolic blood pressure > 90 mmHg)
Liver:
-presence or history of liver tumors (benign or malignant)
-presence or history of severe hepatic disease as long as liver function values have not returned to normal
-jaundice and/or pruritus related to cholestasis
-history of cholestatic jaundice associated with pregnancy or previous COC use
Metabolic diseases:
-uncontrolled diabetes mellitus with vascular involvement
-severe dyslipoproteinemia
Other diseases:
-any known or suspected malignant or premalignant disease
-uncontrolled thyroid disorder
-chronic inflammatory bowel disease
-severe renal insufficiency or acute renal failure
-hemolytic uremic syndrome
-sickle cell anemia
-porphyria
-history of hypertriglyceridemia-associated pancreatitis
-systemic lupus erythematodes, pemphigoid gestationis during a previous pregnancy
-Sydenham chorea
-herpes gestationis
-otosclerosis-related hearing loss
-history of migraine with focal neurologic symptoms
-epilepsy
-current or history of clinically significant depression
-hereditary angioedema
8. Undiagnosed vaginal bleeding
9. Known alcohol, drug, or medicine abuse (e.g., laxatives)
10. Additional sex steroids (excluding topical use of Progestogel®), anticoagulants (e.g., heparin, coumarin); antiepileptics (hydantoin derivatives [e.g., phenytoin] or carboxamide derivatives [e.g., carbamazepine, oxcarbamazepine], other antiepileptics [e.g., felbamate, topiramate]); hypnotics and sedatives (e.g., barbiturate derivatives, primidone); tuberculostatics (e.g., rifampicin); oral antimycotics (except for a so-called single shot treatment) [e.g., griseofulvin, ketoconazole, itraconazole, fluoconazole]; virostatic agents (except for topical use) (e.g., ritonavir); phenylbutazone; products containing St. John’s wort (Hypericum perforatum); and continuous systemic use of antibiotics for >10 days
11. Other hormonal contraceptive methods (oral, transdermal) during treatment (blister in use at randomization should be finished); intra-uterine devices (IUD) with or without hormone release within 1 month prior to Visit 1. Implants within 1 month prior Vis
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