A Multinational, Multicenter, Randomized, Open-Label Study to Evaluate the Impact of a 91-day Extended Cycle Oral Contraceptive Regimen, Compared to two 28-day Standard Oral Contraceptive Regimens, on Hemostatic Parameters in Healthy Women - ND
- Conditions
- Healthy women taking contraceptive regimenMedDRA version: 9.1Level: LLTClassification code 10030971
- Registration Number
- EUCTR2010-023215-34-IT
- Lead Sponsor
- Teva Women`s Health Research
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 240
I.1 Female subjects 18-40 years of age, inclusive, at the time of consent; I.2 Premenopausal, non-pregnant, non-lactating; I.3 Body Mass Index (BMI) = 18 kg/m2 and < 30 kg/m2; I.4 One spontaneous menstrual cycle (that occurs approximately 23-35 days after previous menses or withdrawal bleeding episode) prior to the Screening Visit; I.5 Willing to be randomized to one of three open-label oral contraceptive treatment regimens and willing to adhere to the randomized treatment regimen for the 6-month study period; I.6 Agree to use a non-hormonal method of contraception (such as condom, spermicidal foam, or contraceptive sponge) from the time of consent through the first 7 days of IP use and in situations where 2 or more pills in a row are missed as back up contraception. When intermittent therapies with drugs known to interact with oral contraceptives (OCs) are initiated, another non-hormonal method of contraception must also be used for the entire time the subject receives the therapy and for a minimum of 7 days following discontinuation of the medication; I.7 Able to complete all study procedures; capable of and willing to be present at the study site for all study visits; and I.8 Able and willing to read, understand and sign an informed consent after the nature of the study has been fully explained.
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
E.1 Any condition (history or presence of) which contraindicates the use of combination oral contraceptives (Thrombophlebitis or thromboembolic disorders; known or suspected clotting disorders; thrombogenic valvulopathies or rhythm disorders; Migraine headaches with focal, neurological symptoms; Cerebrovascular or coronary artery disease or myocardial infarction; Diabetes mellitus; Chronic renal disease; Hypertension; Cholestatic jaundice; Major surgery with prolonged immobilization (current or scheduled); Known or suspected carcinoma of the breast, endometrial carcinoma or known or suspected estrogen dependent neoplasia; Undiagnosed abnormal genital bleeding (within 180 days of screening); Impaired liver function or disease, hepatic adenomas or carcinomas; Known or suspected pregnancy) E.2 Concomitant use of sex hormones (estrogens, progestins, and/or androgens or any combination administered by any route) including over-the-counter estrogenic compounds/nutritional supplements or food products with estrogenic or potential estrogenic activity within 30 days prior to the screening visit; E.3 Any history of, or current deep vein thrombosis, pulmonary embolism, or arterial thromboembolic disease; E.4 Any known genetic component for thrombophilia including Factor V Leiden mutation, prothrombin mutation, protein C deficiency, protein S deficiency, or antithrombin III deficiency; E.5 Venous thromboembolic event at age 40 or younger in a parent or sibling of subject; E.6 Acute or chronic severe liver dysfunction or disease. There should be an interval of at least 6 months between subsidence of a viral hepatitis and the start of study medication; E.7 Within 6 months postpartum or post-abortion at the Screening Visit; E.8 Current Smoker; E.9 History of previous clinically significant adverse event while taking hormonal contraceptives; E.10 History of having received injectable hormone therapy (e.g. Depo-Provera) within the 6 months prior to the Screening Visit or has a contraceptive implant in place at the time of the screening visit; E.11 Use of any medication, which could significantly interfere with study assessments or with the efficacy of oral contraceptives within 30 days prior to the Screening Visit; E.12 Known hypersensitivity or previous intolerance to estrogens and/or progestins; E.13 Any clinically significant Pap result that would necessitate further evaluation by biopsy, e.g., ``atypical squamous cells cannot exclude HSIL`` (ASC-H) or ``atypical glandular cells`` (AGC); E.14 History of noncompliance with taking medication(s); E.15 Known or suspected alcohol or drug abuse within 12 months prior to the Screening Visit; E.16 Use of any experimental drug or device within 30 days prior to the Screening Visit; E.17 Known Human immunodeficiency virus (HIV) and/or Hepatitis C positive status; E.18 Any employee or relative of an employee of the Sponsor, any Investigator Site employee or relative of employees working on the study; E.19 Any abnormal finding or condition deemed clinically significant by the investigator on history, screening, or physical exam that contraindicates the use of oral contraceptives; or E.20 Any condition the investigator believes would interfere with the subject’s ability to provide informed consent, comply with study instructions, or which might confound the interpretation of the study results or put the subject at risk.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Secondary Objective: ;Primary end point(s): Primary efficacy endpoint is the change from baseline in Prothrombin fragment 1+2 levels over the 6 month treatment period.;Main Objective: To evaluate the impact of extended cycle oral contraceptive [levonorgestrel 150 mcg+ethinyl estradiol 30 mcg (treatment I)] compared to two standard oral contraceptive [levonorgestrel 150 mcg+ethinyl estradiol 30 mcg (treatment II) and desogestrel 150 mcg+ethinyl estradiol 30 mcg (treatment III)] on hemostatic parameters in healthy women.
- Secondary Outcome Measures
Name Time Method