Clinical Trial: Management of Breakthrough Bleeding During Extended Therapy Use With NuvaRing®

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: The Frequency and Management of Breakthrough Bleeding During Extended Therapy With the Transvaginal Contraceptive Ring

Brief 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 Summary:

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.


Sponsor: Scott and White Hospital & Clinic

Current Primary Outcome: a comparison of days and extent per day of bleeding and spotting within subjects for continuous use pattern of nuvaring. [ Time Frame: 6 months ]

Original Primary Outcome:

  • a comparison of days and extent per day of bleeding and spotting within subjects for 21/7day use pattern during pre-extension treatment and 6 month extended regimens.
  • a comparison of BTB/BTS days and extent per day of bleeding during the 6 month interval for the two patterns.


Current Secondary Outcome:

  • a comparison of choice to switch patterns or stick with randomized pattern for second phase of study (2nd 6 month interval). [ Time Frame: 6 months ]
  • comparisons of all symptoms (pelvic pain, headaches, moodiness, and pain medication use) both within subjects during different treatment intervals and between subject groups. [ Time Frame: 12 months ]


Original Secondary Outcome:

  • a comparison of choice to switch patterns or stick with randomized pattern for second phase of study (2nd 6 month interval).
  • comparisons of all symptoms (pelvic pain, headaches, moodiness, and pain medication use) both within subjects during different treatment intervals and between subject groups.


Information By: Scott and White Hospital & Clinic

Dates:
Date Received: May 16, 2007
Date Started: May 2006
Date Completion:
Last Updated: December 17, 2009
Last Verified: December 2009