Multi-center, open, randomized, parallel group comparison of cycle control for seven cycles and endometrial safety in a subgroup for thirteen cycles of contraceptive patch SH P00331F (0.9 mg ethinylestradiol/1.9 mg gestodene) vs a contraceptive comparator patch (0.75 mg ethinylestradiol/6 mg norelgestromin) in 400 healthy female volunteers - FC patch comparator study
- Conditions
- Contraception
- Registration Number
- EUCTR2004-000821-31-FI
- Lead Sponsor
- Schering AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 400
1. Signed informed consent
2. Healthy female volunteer requesting contraception
3. Age between 18 and 35 years (inclusive), smokers maximum age of 30 years at inclusion
4. a) Pap smear taken or
b) Non-suspicious Pap smear within the last six months prior to start of the study can be
presented in writing (see Section 7.5.1.2 ‘Safety’)
5. At least six free cycles have to follow depot contraception, at least one free cycle has to follow gestodene, norelgestromin/norgestimate containing oral or transdermal contraceptives or removal of hormonal implants, IUD or IUS (Time will be counted from previous use to screening blood sampling.)
6. At least three cycles have to follow delivery, abortion, or lactation before start of treatment
7. For biopsy group only: endometrial biopsy taken at admission visit with a non-suspicious biopsy result
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
1. Pregnancy, lactation
2. Known hypersensitivity to any of the study drug ingredients
3. Any disease or condition that can compromise the function of body systems and which could result in altered absorption, excessive accumulation, impaired metabolism, or altered excretion of the study medication
4. Severe systemic disease that might interfere with the conduct of the study or the interpretation of the results
5. Uncontrolled thyroid disorders
6. Current or history of clinically significant depression in the last year
7. Abnormal, clinically significant findings which, according to the assessment of the investigator, could worsen under hormonal treatment
8. Application of an experimental drug within 30 days prior to inclusion in the study
9. Liver diseases: previous, acute and chronic progressive liver diseases, e. g., disturbances of the bilirubin excretion in the bile (Dubin-Johnson and Rotor syndromes), disturbances of the bile secretion, disturbances in the bile flow (a history of or current cholestasis), idiopathic icterus or pruritus during a former pregnancy or estrogen-progestogen treatment. There should be an interval of at least 6 months between the subsidence of a viral hepatitis (normalization of the liver parameters) and the beginning of study medication application
10. Vascular diseases and coagulation disorders: Existing or previous venous thromboembolic diseases (deep vein thrombosis, pulmonary embolism), existing or previous arterial thromboembolic diseases (myocardial infarction, stroke), and any condition which could increase the risk to suffer any of the above mentioned disorders, e. g. known coagulation disorders, hereditary AT-III, protein-C and/or protein-S deficiency, any venous thromboembolic event that occurred in a close relative at a younger age, specific heart diseases, cardiac or renal dysfunction, varicose veins, previous phlebitis, alterations in cerebral vessels
11. Uncontrolled arterial hypertension (confirmed systolic blood pressure ? 140 mmHg or confirmed diastolic blood pressure ? 90 mmHg)
12. Known skin disease with suspected alteration of dermal absorption (e.g. psoriasis)
13. Significant skin reaction to transdermal preparations or sensitivity to surgical / medical tape
14. Known diabetes mellitus, impaired glucose tolerance
15. Sickle-cell anemia
16. Known disturbances of lipid metabolism
17. Diagnosed or suspected malignant or premalignat disease
18. Other diseases: Pemphigoid gestationis during a previous pregnancy; middle-ear deafness (otosclerosis); endometrial hyperplasia; migraine with neurologic symptoms (complicated migraine); genital bleeding of unknown origin; endometriosis; uterus myomatosus confirmed by ultrasonography; manifest kidney disease with impaired renal function
19. Alcohol, drug, or medicine abuse
20. Prohibited concomitant medication: Use of systemic or topical medications or substances which oppose the study objectives or which might influence them, e.g. additional sex steroids, drugs known to induce (e.g. rifampicin, barbiturates, anticonvulsants, the herbal remedy St. John's Wort (hypericum perforatum)), or inhibit (e.g. ketoconazole, cimetidine, verapamil) liver enzymes, continuous use of antibiotics over a period of more than 10 days (see section 7.3.3)
21. Other contraceptive methods such as sterilization or IUD
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