An Open-Label Study Evaluating Breakthrough Bleeding and Spotting With Norgestimate/Ethinyl Estradiol Tablets Administered as an Extended Regimen

McNeil-PPC

Status and phase

Completed

Phase 2

Conditions

Metrorrhagia

Treatments

Drug: Norgestimate/Ethinyl Estradiol tablet

Study type

Interventional

Funder types

Industry

Identifiers

NCT00344383

CR008344

Details and patient eligibility

About

The purpose of this study is to evaluate the bleeding profile of norgestimate/ethinyl estradiol, an oral contraceptive tablet, given in an extended regimen

Full description

This is an open-label study evaluating the bleeding profile of norgestimate/ethinyl estradiol tablets administered as an extended regimen (84 consecutive days of active tablets followed by seven days medication free) following a traditional regimen of two 28-day cycles (21 days of active tablets, followed by seven days of placebo tablets) of norgestimate/ethinyl estradiol tablets. All patients will receive norgestimate/ethinyl estradiol tablets in a traditional regimen for two 28-day cycles. Following the Traditional Treatment Phase, all patients will receive norgestimate/ethinyl estradiol tablets in an Extended Regimen Treatment Phase, consisting of 84 days of treatment with norgestimate/ethinyl estradiol tablets. Safety evaluations include physical examinations, adverse event reporting and vital signs. The hypothesis of the study is that a triphasic extended regimen would not result in breakthrough bleeding and spotting when the progestin dose drops. Traditional Regimen: two 28 day cycles of norgestimate 180 mcg daily for 1 week, 215 mcg daily for 1 week, 250 mcg daily for 1 week, placebo daily for 1 week. Extended Regimen: four uninterrupted cycles of norgestimate 180 mcg daily for 1 week, 215 mcg daily for 1 week, 250 mcg daily for 1 week, 1 week medication-free. In both Treatment Regimens patients receive ethinyl estradiol 25 mcg in each active tablet. The study is 147 days, Traditional days 1-56 and Extended days 57-147

Enrollment

61 patients

Sex

Female

Ages

18 to 45 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

Subjects in good health as confirmed by medical history, physical exam, and PAP smear within the preceding six months
Non-smokers, if between 35 and 45 years of age
Patients who are not pregnant or lactating
Had at least one normal menstrual period within 35 days prior to screening
Completed their last term pregnancy at least 42 days prior to screening and had at least one normal menstrual period since the last pregnancy
Must be post-menarcheal (have had at least one normal menstrual period) and pre-menopausal (having regular menstrual periods)

Exclusion criteria

History or presence of disorders commonly accepted as contraindications to steroid hormonal therapy, eg, menopause, active or history of deep vein thrombophlebitis, thromboembolic disorders or hypercoagulation disorders, cerebral vascular or coronary artery disease, uncontrolled hypertension, or migraines with focal aura, benign or malignant liver tumor that developed during the use of oral contraceptives or estrogen-containing products
carcinoma of any body system, diabetes mellitus with vascular involvement, known or suspected estrogen-dependent neoplasia, cholestatic jaundice, undiagnosed abnormal vaginal bleeding, neurovascular lesion of the eye, clinically relevant impairment of liver function, liver disease or renal disease
absence of cyclic bleeding for at least three months, recent history of alcohol or other substance abuse
significant depression or psychiatric disease that would result in an unreliable patients
any subject deemed by the investigator to have questionable reliability in her ability to comply with the protocol and provide accurate information.