The Effects of Continuous Administration of a Monophasic Oral Contraceptive on Bleeding Days and Endometrial and Ovarian Function

Completed

Conditions studied: Menstrual Cycle, Healthy

In brief

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 number of vaginal bleeding days in the continuous regimen compared to a traditional 21/7 regimen. In addition, the investigators hypothesize that there will be increased endometrial and ovarian suppression in the CCOCP regimen.

Key facts

Study ID

NCT00128726

Run by

Milton S. Hershey Medical Center

People needed

62

Starts

2001-06-01

Expected to finish

2006-08-01

Last updated by the study team

2012-12-21

Who can join

Age: 18 and older, up to 35. Sex: female. Healthy volunteers: accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• The Penn State Hershey Medical Center — Hershey, Pennsylvania, United States

Full record on ClinicalTrials.gov

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