Status:
COMPLETED
The Effects of Continuous Administration of a Monophasic Oral Contraceptive on Bleeding Days and Endometrial and Ovarian Function
Lead Sponsor:
Milton S. Hershey Medical Center
Conditions:
Menstrual Cycle
Healthy
Eligibility:
FEMALE
18-35 years
Brief Summary
The purpose of this study is to determine the safety and efficacy of a continuous combined oral contraceptive pill (CCOCP) regimen. The investigators hypothesize that there will be a decrease in the n...
Detailed Description
In the U.S. many women of reproductive age use some form of contraception, 23% of whom use estrogen-progesterone combined oral contraceptives. Low-dose oral contraceptives suppress ovulation and domin...
Eligibility Criteria
Inclusion
- Healthy women of legal age of consent between 18-35 years who wish to use a continuous combined oral contraceptive and are non-smokers.
- Must have a regular (25-31) day menstrual cycle for the three month period preceding enrollment.
- Subject will comply with protocol, in the opinion of the investigator.
Exclusion
- Thrombophlebitis
- Known or suspected clotting disorders
- Cerebrovascular or coronary artery disease or myocardial infarction
- Malignancy
- Known or suspected estrogen dependent neoplasia
- Undiagnosed abnormal genital bleeding
- Benign or malignant liver tumor that developed during the use of oral contraceptives or other estrogen-containing products
- Hyperlipidemia - fasting cholesterol level greater than 6.73 mmol/L (260mg); fasting triglyceride level greater than 3.39 mmol/L (300mg/dl); high cholesterol.
- Diabetes mellitus
- Migraine or increased sensitivity of headaches during previous estrogen or oral contraceptive study
- Depression requiring hospitalization or associated with suicidal ideation
- Chronic renal disease
- Known hypersensitivity to estrogens and/or progestogens
- Neuro-ocular disorders
- Cholestatic jaundice
- Pregnancy while taking oral contraceptives
- Persistent non compliance with taking medication
- Serious adverse experiences with oral contraceptive use
- Malabsorption due to illness or surgery
- Use of any experimental drug or device within the last 90 days before study drug administration
- Any anticonvulsant medications
- Any use of rifampin within 3 months of enrollment
- Any use of lipid lowering agents
- Impaired liver function or disease
- Known or suspected pregnancy
- Hypertension whether treated or untreated
- Cervical cytological smear or low grade squamous intraepithelial lesion (SIL) or greater that is untreated within the last year
- The use of an intrauterine device (IUD) or injectable or implantable estrogen, progestogens, or androgens during the six month period before enrollment; or oral contraceptive or sex hormone use within three cycles before enrollment.
- Breast feeding
- Known or suspected alcoholism or drug abuse
- Smoking
Key Trial Info
Start Date :
June 1 2001
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2006
Estimated Enrollment :
62 Patients enrolled
Trial Details
Trial ID
NCT00128726
Start Date
June 1 2001
End Date
August 1 2006
Last Update
December 21 2012
Active Locations (1)
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1
The Penn State Hershey Medical Center
Hershey, Pennsylvania, United States, 17033-0850