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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.
First Received: August 2, 2007   Last Updated: October 2, 2009   History of Changes
Sponsor: Schering-Plough
Information provided by: Schering-Plough
ClinicalTrials.gov Identifier: NCT00511355
  Purpose

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.


Condition Intervention Phase
Contraception
Drug: NOMAC-E2
Drug: Levonorgestrel and Ethinyl Estradiol
Phase III

Study Type: Interventional
Study Design: Prevention, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Official Title: 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

Resource links provided by NLM:


Further study details as provided by Schering-Plough:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 121
Study Start Date: September 2006
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1: Active Comparator
Estradiol and Nomegestrol Acetate
Drug: NOMAC-E2
Estradiol and Nomegestrol Acetate Tablets, 24 active plus 4 placebo tablets per cycle, 2.5 mg NOMAC and 1.5 mg E2
2: Active Comparator
Levonorgestrel and Ethinyl Estradiol Tablets
Drug: Levonorgestrel and Ethinyl Estradiol
Levonorgestrel and Ethinyl Estradiol Tablets, 150 µg LNG and 30 µg EE, up to 6 cycles of 28 days

  Eligibility

Ages Eligible for Study:   18 Years to 50 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Schering-Plough ( Head, Clinical Trials Registry & Results Disclosure Group )
Study ID Numbers: Protocol No. 292004, P05764
Study First Received: August 2, 2007
Last Updated: October 2, 2009
ClinicalTrials.gov Identifier: NCT00511355     History of Changes
Health Authority: Finland: Finnish Medicines Agency

Additional relevant MeSH terms:
Estrogens
Contraceptive Agents
Contraceptives, Oral
Physiological Effects of Drugs
Hormones, Hormone Substitutes, and Hormone Antagonists
Contraceptive Agents, Female
Ethinyl Estradiol
Reproductive Control Agents
Hormones
Estradiol
Pharmacologic Actions
Contraceptives, Oral, Combined
Levonorgestrel
Therapeutic Uses
Contraceptives, Oral, Synthetic

ClinicalTrials.gov processed this record on February 08, 2010