The aim of this monocenter, open-label, randomized study is to determine the ovulation inhibitory effect of the COC SH T04769G (0.15 mg Ethinylestradiol and 1.5 mg Dienogest in a modified release film-coated tablet) and to collect supplementary data regarding the ovulation inhibitory effect of the well-established COC Valette SH D00659AF (0.03 mg Ethinylestradiol and 2.0 mg Dienogest). The intended indication for the product under development is the hormonal contraception. MedDRA version: 9.1 L
Conditions
Interventions
Product Name: Valette low
Product Code: SH T04769G
Pharmaceutical Form: Modified-release tablet
INN or Proposed INN: Ethinylestradiol
CAS Number: 57636
Current Sponsor code: ZK 4944
Concentration unit
Sponsors
Bayer Schering Pharma AG
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - healthy female volunteers aged between 18 and 35 years (inclusive), smokers not older than 30 years (inclusive) at inclusion - follicular diameter >= 15 mm before Visit 6 / admission to treatment or observed ovulation during pre-treatment cycle, absence of premature follicular ripening - non-suspicious cervical smear taken at Screening - 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
Exclusion criteria: - Pregnancy, lactation (less than 3 cycles following delivery, abortion, or lactation before start of pre-treatment cycle) - Known hypersensitivity to any ingredients of the study medication, e.g. patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption - 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 - Uncontrolled thyroid disorders - Clinically significant depression (current or in the last year) - Abnormal, clinically significant findings which, according to the assessment of the investigator, may worsen under hormonal treatment (e.g., pemphigoid gestationis during a previous pregnancy; middle-ear deafness (otosclerosis); sydenham chorea, porphyria, systemic lupus erythematodes, hemolytic uremic syndrome) - Laboratory values outside inclusion range at Screening - Participation in another clinical study or administration of an investigational drug within 1 month prior to study entry (Visit 1) - Operations scheduled in the study period - Liver diseases: acute and chronic progressive liver diseases, e.g., disturbances of the bilirubin excretion of the bile (Dubin-Johnson and Rotor syndromes) , disturbances of the bile secretion, disturbances in the bile flow, idiopathic icterus or pruritus during a previous pregnancy or estrogen-progestogen treatment. Presence or history of liver tumors (benign or malignant) Existing or previous hepatic disease as long as liver function values have not returned to normal. 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. - Pancreatitis or a history thereof if associated with severe hypertriglyceridemia - 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), presence or history of prodromi of a thrombosis (e.g., transient ischemic attack, angina pectoris), existing or previous cerebrovascular accident, as well as any condition that could increase the risk of any of the above, e.g., hereditary or acquired predisposition for venous or arterial thrombosis, such as APC-resistance, Antithrombin III (AT-III) deficiency, Protein-C and/or Protein-S deficiency, hyperhomocysteinemia and antiphospholipid-antibodies (anticardiolipin-antibodies, lupus anticoagulant), any venous thromboembolic event that occurred in a close relative at a younger age (= 50 years), specific heart diseases (e.g., valvular heart disease, atrial fibrillation) cardiac dysfunction (NYHA I-IV), pronounced varicosis veins, mild varicosis veins or previous phlebitis in combination with other risk factors - Uncontrolled arterial hypertension (confirmed systolic blood pressure > 140 mmHg or confirmed diastolic blood pressure > 90 mmHg) - Known diabetes mellitus - Sickle-cell anemia - Known severe disturbances of lipid metabolism - Known or suspected malignant or premalignant steroid-hormone dependent diseases (e.g., endometrial cancer, breast cancer), also a history thereof. Volunteers with other malignancies / premalignanci
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The aim of the study is to determine the ovulation inhibitory effect of the COC SH T04769G (0.015 mg Ethinylestradiol and 1.5 mg Dienogest in a modified release film-coated tablet) and to collect supplementary data regarding the ovulation inhibitory effect of SH D00659AF (0.03 mg Ethinylestradiol and 2.0 mg Dienogest) in treatment cycle 2. Ovulation inhibition will be assessed by TVU of the leading follicle diameter and by analysis of serum hormone levels (estradiol, progesterone). Ovarian activity will be classified according to Hoogland & Skouby (1993). A score of < 6 will be regarded as inhibition of ovulation. ;Secondary Objective: - Grading of ovarian activity according to Hoogland & Skouby (1993) - Follicle size (leading follicle) - Endogenous hormones (estradiol, progesterone, FSH, LH) - Assessment of cervical mucus according to Insler (1972) - Levels of DHEA-S, SHBG, and testosterone (only in volunteers receiving SH D00659AF) - Pharmacokinetic evaluation at steady-state (only in volunteers receiving the test product SH T04769G) ;Primary end point(s): The primary efficacy variable of this study is ovulation inhibition in Treatment Cycle 2 (no/yes), as assessed by ultrasonographic monitoring (TVU) of the leading follicle diameter, and by analysis of serum hormone levels (estradiol, progesterone). Ovarian activity will be classified according to Hoogland & Skouby (1993). A score of < 6 will be regarded as inhibition of ovulation. | — |
Countries
Germany
Outcome results
None listed