An Open-Label Study to Compare the Bleeding Profile of Norelgestromin/Ethinyl Estradiol in an Extended Regimen to Norelgestromin/Ethinyl Estradiol Given in a Traditional Regimen
Condition: Metrorrhagia
MeSH terms: Metrorrhagia; Hemorrhage
Study type: Interventional
Phase: Phase 2

Summary: 
      The purpose of this study is to compare the bleeding profile of norelgestromin/ethinyl
      estradiol given in an extended continuous regimen to norelgestromin/ethinyl estradiol given
      in a traditional cyclic regimen
    

Detailed description: 
      Norelgestromin/ethinyl estradiol is a contraceptive patch shown to be safe and effective for
      the prevention of pregnancy. The usual treatment regimen is three consecutive seven-day
      patches followed by one patch-free week. This cyclic method is followed in order to mimic the
      28-day menstrual cycle. An extended contraceptive regimen (administration of active hormones
      for greater than 21 days) of oral contraceptives is a common practice among women wishing to
      delay or prevent withdrawal bleeding for reasons such as athletic participation or going on
      vacation. In addition to the convenience of reducing the frequency of withdrawal bleeds,
      elimination of the hormone-free interval reportedly reduces many menstrually-related symptoms
      (headaches, pelvic pain, breast tenderness, bloating, swelling) that occur at a greater
      frequency during the hormone-free interval than during the rest of the cycle. Headache is one
      of the most common adverse effects associated with hormonal contraceptive use. Studies have
      demonstrated that headaches were reduced in subjects using extended intervals of active
      hormone. However, one of the main side effects reported with extended regimens is
      breakthrough bleeding and/or spotting. Compared to cyclic regimens, extended oral
      contraceptive use may be associated with an increased incidence of breakthrough bleeding and
      spotting, especially during the first few months of use. This is a randomized (patients are
      assigned different treatments based on chance), open-label, multicenter study comparing the
      bleeding profile of norelgestromin/ethinyl estradiol patch continuous regimen to
      norelgestromin/ethinyl estradiol patch cyclic regimen. Safety evaluations include adverse
      event reporting, physical examinations, blood levels, and vital signs. The hypothesis of the
      study is that norelgestromin/ethinyl estradiol in an extended regimen of 84 days of active
      hormone would result in fewer days and episodes of bleeding compared to a traditional cyclic
      regimen of norelgestromin/ethinyl estradiol. Patients receive norelgestromin/ethinyl
      estradiol patches in a plastic sleeve. In the extended regimen patches will be applied weekly
      for 12 consecutive weeks followed by one week patch-free and then another three consecutive
      weeks of weekly patch applications. In the cyclic regimen patches will be applied for four
      consecutive cycles where each cycle consists of three weekly patch applications followed by
      one week patch-free. The total duration of treatment period is 112 days for each regimen.
    

Intervention name(s): norelgestromin/ethinyl estradiol
Intervention type(s): Drug
Intervention MeSH terms: Ethinyl Estradiol; Norelgestromin; Estradiol
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Metrorrhagia; oral contraception; breakthrough bleeding; spotting