A clinical research study to evaluate the impact of an experimental birth control drug on hemostatic parameters (characteristics of the blood) compared to a standard marketed birth control pill in healthy women.
- Conditions
- The impact of an experimental birth control drug on hemostatic parameters (characteristics of the blood) compared to a standard marketed birth control pill in healthy women(contraceptive)MedDRA version: 14.0Level: PTClassification code 10030970Term: Oral contraceptionSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Health Care [N] - Population Characteristics [N01]
- Registration Number
- EUCTR2011-002602-78-DE
- Lead Sponsor
- Teva Women's Health Research&Development, a division of Teva Branded Pharmaceutical Products R&D, Inc.
- 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, not breast-feeding for a period of 2months prior to the Screening Visit
I.3 Body Mass Index (BMI) = 18 kg/m2 and < or equal 30 kg/m2;
I.4 One spontaneous menstrual cycle (that occurs approximately 23-35 days after previous menses or withdrawal bleeding episode)prior to or concurrent with the Screening Period
I.5 Willing to be randomized to one of two open-label oral contraceptive treatment regimens and willing to adhere to the randomized treatment regimen for the 6-month study period;
I.6 Not at risk for pregnancy or willing and able to use an effective method of nonhormonal contraception (non-hormone releasing IUD, diaphragm, spermicidal foam, contraceptive sponge, condoms) from the time of signed informed consent through last dose of IMP;
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: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 240
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; uncontrolled or untreated hypertension; cholestatic jaundice; major surgery with prolonged immobilization;
carcinoma of the breast; endometrial carcinoma or estrogen dependent neoplasia; undiagnosed abnormal genital bleeding;
impaired liver function or disease; hepatic adenomas or carcinomas;
pregnancy
E.2 Concomitant use of sex hormones
E.3 Any history of, or current deep vein thrombosis, pulmonary embolism, or arterial thromboembolic disease;
E.4 Venous thromboembolic event in a parent or sibling subject.
E.5 Acute or chronic severe liver dysfunction or disease.
E.6 Within 2 months postpartum or post-abortion at the Screening Visit;
E.7 Smoker and age = 35 years
E.8 History of a previous clinically significant adverse event while taking hormonal contraceptives that contraindicates the use of hormonal contraceptives;
E.9 History of having received injectable hormone therapy
or has a contraceptive implant in place
E.10 Use of any medication, which could significantly interfere with study assessments or with the efficacy of oral contraceptives
E.11 Known hypersensitivity or previous intolerance to estrogens and/or progestins;
E.12 Any clinically significant Pap result that would necessitate further evaluation by biopsy;
E.13 History of noncompliance with taking medication(s);
E.14 Known or suspected alcohol or drug abuse
E.15 Use of any experimental drug or device
E.16 Known human immunodeficiency virus (HIV) and/or Hepatitis C positive status;
E.17 Any employee or relative of an employee of the Sponsor, any Investigator Site employee or relative of employees working on the study;
E.18 Any abnormal finding or condition deemed clinically significant by the Investigator or Sponsor that contraindicates the use of oral contraceptives; or
E.19 Any condition or finding the Investigator or Sponsor 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 Main Objective: The purpose of this study is to evaluate hemostatic parameters for the contraceptive regimen DR-102 (Treatment I) compared to active comparator.;Secondary Objective: -;Primary end point(s): The primary endpoint is the change from baseline in Prothrombin Fragment 1+2 (F1+2) ;Timepoint(s) of evaluation of this end point: Change from baseline at week 11 and 23.<br>
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Secondary endpoints <br>The change from baseline in the following secondary endpoints <br><br>-D-dimer, APTT and ETP based APC resistance, Factor II, Factor VII, Factor VIII, Antithrombin, Protein C, and Free and Total Protein S;<br>-Total Cortisol and Corticosteroid Binding Globulin (CBG);<br>-Thyroid Stimulating Hormone (TSH); <br>-Sex Hormone Binding Globulin (SHBG);Timepoint(s) of evaluation of this end point: Change from baseline at week 11 and 23.