Single-center, open-label, uncontrolled study to investigate the effects of the transdermal contraceptive patch containing 0.55 mg ethinylestradiol and 2.1 mg gestodene (material no. 80876395) on the endometrium in a 21-day regimen for 13 cycles in 80 healthy women - Transdermal contraceptive patch - endometrial effects study
- Conditions
- Healthy volunteer trial, intended indication: Prevention of pregnancyMedDRA version: 9.1Level: LLTClassification code 10060346Term: Transdermal contraception
- Registration Number
- EUCTR2009-010599-45-DE
- Lead Sponsor
- Bayer HealthCare AG
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 0
1.Signed and dated informed consent
2.Healthy woman requesting contraception
3.Age: 18 – 35 years (inclusive); smokers must not be older than 30 years at the time of informed consent
4.Normal 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 previous 6 months)
5.History of regular cyclic menstrual periods
6.Normal endometrial biopsy not requiring further follow-up.
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 or lactation (less than 3 menstrual cycles since delivery, abortion, or lactation before start of treatment)
2.Obesity (Body Mass Index > 30.0 kg/m2)
3.Hypersensitivity to any ingredient of the study drug
4.Significant skin reaction to transdermal preparations or sensitivity to surgical/medical tape
5.Safety relevant laboratory values outside inclusion range before start of treatment
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 drug
7.Any diseases or conditions that might interfere with the conduct of the study or the interpretation of the results
8.Any disease or condition that may worsen under hormonal treatment such as:
Cardiovascular
-presence or a history of venous or arterial thrombotic/thromboembolic events or of a cerebrovascular accident, including prodromi and conditions that could increase the risk to suffer from any of the above mentioned disorders
-repeated measurements of systolic blood pressure > 140 mm Hg and/or diastolic blood pressure > 90 mm Hg
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 (Gilbert’s syndrome excepted)
-history of cholestatic jaundice associated with pregnancy or previous COC use
Metabolic diseases
-uncontrolled diabetes mellitus and/or diabetes mellitus with vascular involvement
-severe dyslipoproteinemia
Other diseases
-malignant or premalignant disease
-uncontrolled thyroid disorder
-severe renal insufficiency or acute renal failure
-history of hypertriglyceridemia-associated pancreatitis
-pemphigoid gestationis during a previous pregnancy
-history of herpes gestationis
-otosclerosis-related hearing loss
-history of migraine with focal neurologic symptoms
-epilepsy
-clinically significant depression
-hereditary angioedema
9.Undiagnosed abnormal genital bleeding
10.Abuse of alcohol, drugs, or medicines (e.g., laxatives)
11.Other contraceptive methods:
-long-acting preparations
12.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
13.Simultaneous participation in another clinical trial or participation in another clinical trial prior to study entry that might have an impact on the study objectives, at the discretion of the investigator
14.Major surgery scheduled during the study period
15.Subject is a dependent person
16.Inability to cooperate with the study procedures for any reason, including the following examples: language comprehension, psychiatric illness, inability to get to the study site.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: The primary objective of this study is to investigate the effect of the transdermal contraceptive patch (material no. 80876395, FC Patch Low containing 0.55 mg EE and 2.1 mg GSD) on the endometrium. ;Secondary Objective: The secondary objectives are contraceptive efficacy and safety profile.<br>Additionally, compliance and subjective assessment of the treatment will be evaluated. <br>;Primary end point(s): Effect on the endometrium at cycle 13
- Secondary Outcome Measures
Name Time Method