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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)
This study has been completed.
Study NCT00511355   Information provided by Schering-Plough
First Received: August 2, 2007   Last Updated: October 2, 2009   History of Changes

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 ]
  • 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 ]
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 ]
  • 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 ]
 
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.

 
Phase III
Interventional
Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Contraception
  • Drug: NOMAC-E2
  • Drug: Levonorgestrel and Ethinyl Estradiol
  • Active Comparator: Estradiol and Nomegestrol Acetate
  • Active Comparator: Levonorgestrel and Ethinyl Estradiol Tablets
 

*   Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
 
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.
Female
18 Years to 50 Years
Yes
Contact information is only displayed when the study is recruiting subjects
 
 
NCT00511355
Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
Protocol No. 292004, P05764
Schering-Plough
 
 
Schering-Plough
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP