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)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Contraception
Intervention: NOMAC-E2 (Drug); Levonorgestrel and Ethinyl Estradiol (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp.
Summary
The primary purpose of this study is to evaluate the effects of the combined oral
contraceptive (COC) NOMAC-E2 on hemostasis, lipids, carbohydrate metabolism, adrenal
function, and thyroid function.
Clinical Details
Official title: A Randomized, Open-Label, Comparative, Multi -Center Trial to Evaluate the Effects on Hemostasis, Lipids and 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
Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Prevention
Primary outcome: Serum Concentration of Prothrombin Fragments 1 + 2Serum Concentration of D-Dimer Activated Protein C (APC) Resistance Ratio (Endogenous Thrombin Potential [ETP]-Based) Serum Concentration of Clotting Factor VIIa Serum Concentration of Clotting Factor VIIc Serum Concentration of Clotting Factor VIII Serum Concentration of Clotting Factor II Serum Concentration of Antithrombin III Serum Concentration of Protein S (Free) Serum Concentration of Protein S (Total) Serum Concentration of Protein C APC Resistance Ratio (Activated Partial Thromboplastin Time [APTT]-Based) Serum Concentration of Sex Hormone Binding Globulin (SHBG) Serum Concentration of C-Reactive Protein (CRP) Serum Concentration of Total Cholesterol Serum Concentration of High Density Lipoprotein (HDL)-Cholesterol Serum Concentration of HDL2-cholesterol Serum Concentration of HDL3-cholesterol Serum Concentration of Low Density Lipoprotein (LDL)-Cholesterol Serum Concentration of Apolipoprotein A-1 Serum Concentration of Apolipoprotein B Serum Concentration of Lipoprotein(a) Serum Concentration of Total Triglycerides Area Under the Curve Over 3 Hours (AUC3) for Glucose (Oral Glucose Tolerance Test [OGTT]) Incremental AUC3 for Glucose (OGTT) AUC3 for Insulin (OGTT) Incremental AUC3 for Insulin (OGTT) Serum Concentration of Hemoglobin Type A1c (HbA1c) Serum Concentration of Total Cortisol Serum Concentration of Corticosteroid Binding Globulin (CBG) Serum Concentration of Thyroid Stimulating Hormone (TSH) Serum Concentration of Free Thyroxine (T4) Serum Concentration of Thyroxin Binding Globulin (TBG)
Secondary outcome: Serum Concentration of Total TestosteroneSerum Concentration of Free Testosterone Serum Concentration of Dehydroepiandrosterone Sulphate (DHEAS) Serum Concentration of Androstenedione Serum Concentration of Dihydrotestosterone (DHT) Number of In-treatment Pregnancies (With +2 Day Window) Per 100 Woman Years of Exposure (Pearl Index) Number of Participants With an Occurrence of Breakthrough Bleeding/Spotting Number of Participants With an Occurrence of Absence of Withdrawal Bleeding Number of Participants With an Occurrence of Breakthrough Bleeding Number of Participants With an Occurrence of Breakthrough Spotting (Spotting Only) Number of Participants With an Occurrence of Early Withdrawal Bleeding Number of Participants With an Occurrence of Continued Withdrawal Bleeding Average Number of Breakthrough Bleeding/Spotting Days Average Number of Withdrawal Bleeding/Spotting Days
Eligibility
Minimum age: 18 Years.
Maximum age: 50 Years.
Gender(s): Female.
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.
Locations and Contacts
Additional Information
Starting date: September 2006
Last updated: November 14, 2014
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