A single-center, open-label, controlled, randomized study to investigate the impact of a sequential oral contraceptive containing estradiol valerate and dienogest (SH T00658ID) as compared to a sequential oral contraceptive containing ethinylestradiol and levonorgestrel (SH D00264A) on plasma lipids, hemostatic variables, and carbohydrate metabolism in 60 healthy female volunteers aged 18-50 years over 7 treatment cycles - Metabolism study vs Triquilar 21+7

• Conditions: Contraception

• Registration Number: EUCTR2004-001614-13-DE
• Lead Sponsor: Schering AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2004-12-23
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 60

Inclusion Criteria

- Healthy female volunteers requiring contraception
- Age between 18 and 50 years (inclusive) at Visit 1, smokers not older than 30
years and with a daily cigarette consumption not exceeding 10
- Non-suspicious cervical smear taken at Visit 1 or within the last 6 months before
Visit 1
- Signed and dated informed consent.
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

Exclusion Criteria

- Pregnancy, lactation
- Occurrence of less than 3 menstrual cycles before Visit 1 following delivery,
abortion, or lactation
- Amenorrhoea
- Known hypersensitivity to any ingredient of the study drugs
- Any known diseases or conditions that 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 known severe systemic disease that might interfere with the conduct of the
study or the interpretation of the results
- Known thyroid disorders
- Clinically significant depression (current or in the last year)
- Any known abnormal clinically significant findings which, according to the
assessment of the Investigator, may worsen under hormonal treatment
- Laboratory values outside the inclusion range at Screening
- Participation in another clinical study or administration of an investigational drug
within 1 month prior to Visit 1
- Operations scheduled in the study period

Known liver diseases:
- Previous, acute and chronic progressive liver diseases, e.g., disturbances of
bilirubin excretion in the bile (Dubin-Johnson and Rotor syndromes), disturbances of
bile secretion, disturbances of bile flow (cholestasis, also a history thereof,
idiopathic icterus or pruritus during a former pregnancy or estrogen-progestin
treatment)
- Between the subsidence of a viral hepatitis (normalization of liver parameters) and
the beginning of the study there must be an interval of at least 6 months
- Previous or current liver tumors.

Known vascular and metabolic diseases:
- Existing or previous venous thromboembolic diseases (deep vein thrombosis,
pulmonary embolism), existing or previous arterial thromboembolic diseases
(myocardial infarction, stroke), as well as any condition increasing the disposition to
any of the above, e.g., coagulation disorders with tendency to blood clot formation,
hereditary anti-thrombin III deficiency, protein-C and/or protein-S deficiency, any
venous thromboembolic event occurred in a close relative (parent or sibling) at a
young age ( dysfunction (NYHA I-IV), strong predisposition to varicosis veins, previous phlebitis
- Known arterial hypertension (persistent systolic blood pressure > 140 mmHg
and/or diastolic blood pressure > 90 mmHg)
- Known diabetes mellitus, impaired glucose tolerance
- Known disturbances of lipid metabolism.

Known sickle-cell anemia
- Known or suspected malignant or premalignant disease, in particular steroid-
hormone dependent malignant or premalignant diseases (e.g., endometrial cancer,
breast cancer), also a history thereof

Known other diseases:
- Pemphigoid gestationis during a previous pregnancy, middle-ear deafness
(otosclerosis), endometrial hyperplasia, genital bleeding of unknown origin,
migraine with neurological symptoms (complicated migraine), manifest kidney
disease with impaired renal function, porphyria

Known alcohol, drug, or medicine abuse (e.g., laxatives)

Prohibited concomitant medication:
- Additional sex steroids, hydantoins (e.g., phenytoin), barbiturates (e.g.,
primidone), carbamazepine, rifampicin, griseofulvin, phenylbutazone, the herbal
remedy St. John´s Wort, continuous use of antibiotics (e.g., ampicillin, tetracycline)
for >10 days, any anticoagulatory drugs (e.g, heparin, coumarin)

Sex hormones prior to start of treatme

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To confirm the safety of SH T00658ID with regard to plasma lipids, haemostatic variables, and carbohydrate metabolism ;Secondary Objective: The effects on thyroid parameters, sex hormone-binding globulin (SHBG), and cortisol-binding globulin (CBG) will also be investigated.;Primary end point(s): Lipid profile: <br>Intraindividual relative changes (in percent) between Treatment Cycle 7 (Visit 4) and Baseline (Visit 2) in:<br>- High-density lipoprotein (HDL)-cholesterol<br>- Low-density lipoprotein (LDL)-cholesterol (calculated according to Friedewald)