Management of Breakthrough Bleeding During Extended Therapy Use With NuvaRing®
Condition: Breakthrough Bleeding; Breakthrough Spotting
MeSH terms: Metrorrhagia; Hemorrhage
Study type: Interventional

Summary: 
      The purpose of this research study is to evaluate the best way to manage breakthrough
      spotting and bleeding during an extended use regimen of NuvaRing®. Ease of use and
      acceptability of a flexible regimen of NuvaRing® will also be evaluated. A comparison of
      cyclic mood symptoms, pelvic pain, and headaches will be made between a standard 21/7 regimen
      and an extended regimen.
    

Detailed description: 
      Hormonal contraception is undergoing a change away from a 21/7 day regimen where a woman
      utilizes a combination estrogen and progestin therapy for 21 days followed by 7 days of a
      hormone-free interval (HFI). It is well documented that women may experience a higher
      incidence of mood changes, headaches and cramping that begin prior to and during this 7 day
      HFI. By reducing the HFI and extending the active combination contraceptive therapy, it is
      hoped that women will experience greater satisfaction with their contraceptive regimen and
      will experience fewer negative side effects associated with a HFI.

      The most common reason for discontinuation of an extended contraception regimen is irregular
      bleeding. The purpose of this research study is to evaluate the best way to manage this
      breakthrough spotting and bleeding. Ease of use and acceptability of a flexible regimen of
      NuvaRing will also be evaluated. A comparison of cyclic mood symptoms, pelvic pain, and
      headaches will be made between a standard 21/7 regimen and an extended regimen.

      The contraceptive ring used in this study contains both an estrogen (ethinyl estradiol) and a
      progestin (etonogestrel). These are synthetic (man-made) hormones. The amount of ethinyl
      estrogen released into the bloodstream each day is 120mcg and the amount of etonogestrel is
      150mcg. The NuvaRing®, by Organon, is FDA approved for contraception, but is not approved for
      use in an extended regimen. Therefore its use in this study is considered investigational.
    

Intervention name(s): remove ring if bleeding or spotting occurs more than 5 days; If bleeding does not remove ring
Intervention type(s): Other; Other
Intervention description(s): Both groups of women will be using the nuvaring continuously, ie if the ring is placed on 3rd of January, on the 3rd of February the ring would be removed and a new one inserted. On the 3rd of March the same thing would happen and so forth. Group 2 if bleeding or spotting occurs for more than 5 days then on the 6th day the ring is removed and will keep it out for three more days and reinsert the same ring on the 4th day.; Subject is using the nuvaring continuously. For example she puts the ring in on 3rd of January then the 3rd of February is when that ring is removed and another one is inserted. The 3rd of March the same thing occurs.
Other intervention name(s): etonogestrel/ethinyl estradiol; nuvaring; etonogestrel/ethinyl estradiol; vaginal ring
Intervention MeSH terms: Estradiol 17 beta-cypionate; Estradiol 3-benzoate; Ethinyl Estradiol; Etonogestrel; Desogestrel; NuvaRing; Estradiol; Polyestradiol phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: spotting; PMS; nuvaring; birth control; pelvic pain; headache; mood swings; continuous use