| August 2, 2007 |
| October 2, 2009 |
| September 2006 |
| January 2008 (final data collection date for primary outcome measure) |
- Effects on hemostasis as determined by prothrombin fragment 1+2, D-dimer, APC resistance ratio (ETP-based), factors VIIa / VIIc / VIII / II, antithrombin, protein S (free and total), protein C, APC resistance ratio (APTT -based), SHBG and CRP [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Effects on lipid metabolism as determined by total cholesterol, HDL-, HDL2, HDL3 and LDL cholesterol, apolipoproteins A-1 and B, lipoprotein (a) and total
triglycerides. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Effects on carbohydrate metabolism as determined by oral glucose tolerance test (including fasting glucose and insulin) and HbA1C. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Effects on adrenal function as determined by total cortisol and corticosteroid binding globulin (CBG). [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Effects on thyroid function as determined by thyroid stimulating hormone (TSH), free T4, thyroxin binding globulin (TBG). [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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- Effects on hemostasis as determined by prothrombin fragment 1+2, D-dimer, APC resistance ratio (ETP-based), factors VIIa / VIIc / VIII / II, antithrombin, protein S (free and total), protein C, APC resistance ratio (APTT-based), SHBG and CRP. [ Time Frame: 6 months ]
- Effects on lipid metabolism as determined by total cholesterol, HDL-, HDL2, HDL3 and LDL cholesterol, apolipoproteins A-1 and B, lipoprotein (a) and total
triglycerides. [ Time Frame: 6 months ]
- Effects on carbohydrate metabolism as determined by oral glucose tolerance test (including fasting glucose and insulin) and HbA1C. [ Time Frame: 6 months ]
- Effects on adrenal function as determined by total cortisol and corticosteroid binding globulin (CBG). [ Time Frame: 6 months ]
- Effects on thyroid function as determined by thyroid stimulating hormone (TSH), free T4, thyroxin binding globulin (TBG). [ Time Frame: 6 months ]
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| Complete list of historical versions of study NCT00511355 on ClinicalTrials.gov Archive Site |
- Effects on androgen levels as determined by total and free testosterone, dehydroepiandrosterone sulphate (DHEAS), androstenedione, dihydrotestosterone (DHT). [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Contraceptive efficacy as determined by serum HCG pregnancy test (or home pregnancy test). [ Time Frame: 6 months ] [ Designated as safety issue: No ]
- Drug safety as determined by [S]AE monitoring, cervical cytology, physical & gynecological exams, vital signs, and routine laboratory parameters. [ Time Frame: 6 months ] [ Designated as safety issue: Yes ]
- Cycle control as determined by patient diary records. [ Time Frame: 6 months ] [ Designated as safety issue: No ]
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- Effects on androgen levels as determined by total and free testosterone, dehydroepiandrosterone sulphate (DHEAS), androstenedione, dihydrotestosterone (DHT). [ Time Frame: 6 months ]
- Contraceptive efficacy as determined by serum HCG pregnancy test (or home pregnancy test). [ Time Frame: 6 months ]
- Drug safety as determined by [S]AE monitoring, cervical cytology, physical & gynecological exams, vital signs, and routine laboratory parameters. [ Time Frame: 6 months ]
- Cycle control as determined by patient diary records. [ Time Frame: 6 months ]
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| Effects on Hemostasis, Lipids, Carbohydrate Metabolism, Adrenal & Thyroid Function of the Combined Oral Contraceptive NOMAC-E2 Compared to a COC Containing LNG/EE (292004)(COMPLETED)(P05764) |
| A Randomized, Open-Label, Comparative, Multi -Center Trial to Evaluate the Effects on Hemostasis, Lipids, Carbohydrate Metabolism, and on Adrenal and Thyroid Function of a Monophasic COC Containing 2.5 mg NOMAC and 1.5 mg E2 Compared to a Monophasic COC Containing 150 ug LNG and 30 ug EE |
The primary purpose of this study is to evaluate the effects of the combined oral contraceptive NOMAC-E2 on hemostasis, lipids, carbohydrate metabolism, adrenal function, and thyroid function. |
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| Phase III |
| Interventional |
| Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study |
| Contraception |
- Drug: NOMAC-E2
- Drug: Levonorgestrel and Ethinyl Estradiol
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- Active Comparator: Estradiol and Nomegestrol Acetate
- Active Comparator: Levonorgestrel and Ethinyl Estradiol Tablets
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| Completed |
| 121 |
| January 2008 |
| January 2008 (final data collection date for primary outcome measure) |
Inclusion Criteria:
- Sexually active women, at risk for pregnancy and not planning to use during trial medication use;
- Women in need for contraception and willing to use an oral contraceptive (OC) for 6 months (6 cycles);
- At least 18 but not older than 50 years of age at the time of screening;
- Body mass index = 17 and = 29 kg/m^2;
- Good physical and mental health;
- Willing to give informed consent in writing
Exclusion Criteria:
- Present use or use within 2 months prior to screening of any other hormonal treatment including sex hormones (other than contraceptives), insulin, thyroid and corticosteroid hormones (with the exception for local dermatological use);
- Contraindications for contraceptive steroids
- Presence or history (within 1 year before screening) of alcohol or drug abuse as judged by the (sub)investigator.
- An abnormal cervical smear (i.e.: dysplasia, cervical intraepithelial neoplasia [CIN], SIL, carcinoma in situ, invasive carcinoma) at screening or documentation of an abnormal smear performed within 6 months before screening;
- Clinically relevant abnormal laboratory result at screening as judged by the (sub) investigator;
- Use of an injectable hormonal method of contraception prior to screening; within 6 months of an injection with a 3 -month duration, within 4 months to screening of an injection with a 2-month duration, within 2 months of an injection with a 1-month duration;
- Before spontaneous menstruation has occurred following a delivery or abortion;
- Breastfeeding or within 2 months after stopping breastfeeding prior to the start of trial medication;
- Present use or use within 2 months prior to the start of the trial medication of the following drugs: phenytoin, barbiturates, primidone, carbamazepine, oxcarbazepine, topiramate, felbamate, rifampicin, nelfinavir, ritonavir, griseofulvin, ketoconazole, lipid-lowering drugs, anticoagulants and herbal remedies containing Hypericum perforatum (St John's Wort);
- Use of pharmacological agents which affect the hemostatic system during the pretreatment blood sampling: vitamin K (only prohibited within two weeks prior to sampling), nonsteroidal anti-inflammatory drugs (NSAIDS) and aspirin (both only prohibited during the week prior to sampling);
- Administration of investigational drugs and/or participation in another clinical trial within 2 months prior to the start of the trial medication or during the trial period.
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| Female |
| 18 Years to 50 Years |
| Yes |
| Contact information is only displayed when the study is recruiting subjects |
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| NCT00511355 |
| Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough |
| Protocol No. 292004, P05764 |
| Schering-Plough |
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| Schering-Plough |
| October 2009 |