Status:
COMPLETED
An Open-Label Study Evaluating Breakthrough Bleeding and Spotting With Norgestimate/Ethinyl Estradiol Tablets Administered as an Extended Regimen
Lead Sponsor:
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Conditions:
Metrorrhagia
Eligibility:
FEMALE
18-45 years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the bleeding profile of norgestimate/ethinyl estradiol, an oral contraceptive tablet, given in an extended regimen
Detailed 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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
November 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2004
Estimated Enrollment :
61 Patients enrolled
Trial Details
Trial ID
NCT00344383
Start Date
November 1 2003
End Date
July 1 2004
Last Update
March 4 2011
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