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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)

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 + 2

Serum 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 Testosterone

Serum 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

Page last updated: August 23, 2015

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