The Effects of Continuous Administration of a Monophasic Oral Contraceptive on Bleeding Days and Endometrial and Ovarian Function
Condition: Menstrual Cycle; Healthy
MeSH terms: Hemorrhage
Study type: Observational

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 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.
    

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 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.
    

Observational model: Cohort
Time perspective: Prospective
Sampling method: Probability Sample
Study population: 
        Healthy women between 18-35 years of age who wish to use a continuous combined oral
        contraceptive and are non-smokers. Must have regular menstrual cycles for a 3 month period.
      
Biospecimen description: 
      whole blood, urines, tissue
    
Keywords: continuous combined oral contraceptive; endometrial and ovarian suppression