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)

Organon

Status and phase

Completed

Phase 3

Conditions

Contraception

Treatments

Drug: Levonorgestrel and Ethinyl Estradiol

Drug: NOMAC-E2

Study type

Interventional

Funder types

Industry

Identifiers

NCT00511355

P05764

Organon Protocol No. 292004

Details and patient eligibility

About

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.

Enrollment

121 patients

Sex

Female

Ages

18 to 50 years old

Volunteers

Accepts Healthy Volunteers

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.