The Effects of Continuous Administration of a Monophasic Oral Contraceptive on Bleeding Days and Endometrial and Ovarian Function
18 Years
35 Years
Female
Menstrual Cycle, Healthy
Trial Information
The Effects of Continuous Administration of a Monophasic Oral Contraceptive on Bleeding Days and Endometrial and Ovarian Function
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 dominant follicle selection by inhibiting luteinizing hormone and follicle
stimulating hormone secretion by the pituitary gland. Under social, cultural and religious
influences, women have traditionally been prescribed oral contraceptives in a pattern of 21
days of active pills with seven days of inactive pills as a way of mimicking the natural
menstrual cycle and provide reassurance of the absence of pregnancy by a withdrawal bleed
during the placebo period. However, the withdrawal bleeding that occurs during the placebo
period may still present with debilitating menstrual symptoms such as cramping, spotting
break through bleeding, menstrual migraines and anemia. These menstrual disorders remain
one of the most common reasons for prescribing the oral contraceptives. Suppression of
bleeding by discarding the seven placebo tablets has been advocated for women with severe
mental disabilities that impair hygiene and proper use, as well as for occasional use by
women inconvenienced by menstruation (i.e. female athletes during competition and women in
the military). Additionally, many physicians have used oral contraceptive pill regimens to
treat endometriosis, premenstrual syndrome, anovulatory dysfunctional uterine bleeding,
acne, hirsutism and anemia. The seven day pills free ovarian axis and ovarian follicular
development and increase ovarian sex steroid production which may result in mild
exacerbations of the treated condition. There is a growing patient preference to avoid
vaginal bleeding completely, both in pre-menopausal and post-menopausal hormone replacement
regimens in the general population. This is reflected in a woman's attitude about changing
menstrual bleeding patterns as assessed by a 1996 Dutch survey. The majority of women in
all studied age groups said that they would prefer decreasing the frequency of bleeding to
less than once a month or completely eliminating menses altogether through the use of oral
contraceptives. Therefore, reducing bleeding days is an important goal for improving
quality of life in women suffering from the discomfort and inconvenience of withdrawal
bleeding.
Inclusion Criteria:
- 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 Criteria:
- 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
Type of Study:
Observational
Study Design:
Observational Model: Cohort, Time Perspective: Prospective
Principal Investigator
Richard S Legro, M.D.
Investigator Role:
Principal Investigator
Investigator Affiliation:
The Penn State Hershey Medical Center/College of Medicine
Authority:
United States: Institutional Review Board
Study ID:
HY01-190
NCT ID:
NCT00128726
Start Date:
June 2001
Completion Date:
August 2006
Related Keywords:
- Menstrual Cycle
- Healthy
- continuous combined oral contraceptive
- endometrial and ovarian suppression
- Hemorrhage
- Adenoma
Name | Location |
|---|---|
| The Penn State Hershey Medical Center | Hershey, Pennsylvania 17033-0850 |
