Management of Breakthrough Bleeding During Extended Therapy Use With NuvaRing®

This study has been completed.
Sponsor:
Collaborator:
Organon
Information provided by:
Scott and White Hospital & Clinic
ClinicalTrials.gov Identifier:
NCT00475553
First received: May 16, 2007
Last updated: December 17, 2009
Last verified: December 2009
  Purpose

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.


Condition Intervention
Breakthrough Bleeding
Breakthrough Spotting
Other: remove ring if bleeding or spotting occurs more than 5 days
Other: If bleeding does not remove ring

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: The Frequency and Management of Breakthrough Bleeding During Extended Therapy With the Transvaginal Contraceptive Ring

Resource links provided by NLM:


Further study details as provided by Scott and White Hospital & Clinic:

Primary Outcome Measures:
  • a comparison of days and extent per day of bleeding and spotting within subjects for continuous use pattern of nuvaring. [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Enrollment: 75
Study Start Date: May 2006
Study Completion Date: May 2008
Primary Completion Date: May 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Group 2
Subject will use the nuvaring and if they developed breakthrough bleeding or spotting for more than 5 days on the 6th day the ring would be removed and would leave it out for 3 full days and reinsert the same ring the next day. All subjects would be filling out a daily diary or calendar which would rate their blood flow, pelvic pain, headaches, moods, how many pain pills were taken and how many pads, liners or tampons would be used.
Other: remove ring if bleeding or spotting occurs more than 5 days
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.
Other Name: etonogestrel/ethinyl estradiol
Group 1
Subject is using the nuvaring continuously and it would be changed out monthly. If she develops breakthrough bleeding or spotting she does not remove the ring until it is her time to change it. All subjects would be filling out a daily diary or calendar which would rate their blood flow, pelvic pain, headaches, moods, how many pain pills were taken and how many pads, liners or tampons would be used.
Other: If bleeding does not remove ring
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 Names:
  • nuvaring
  • etonogestrel/ethinyl estradiol
  • vaginal ring

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.

  Eligibility

Ages Eligible for Study:   18 Years to 45 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Age 18-45 years of age
  • Currently utilizing combination estrogen/progestin contraception for a period of at least 2 months or 1 month if previously using a progestin only pill.

Exclusion Criteria:

  • Body Mass Index (BMI) of 38 or greater
  • Anyone who should not be using hormonal contraception due to contraindications
  • Anyone who smokes > 10 cigarettes per day or if 35 years old or older smokes any cigarettes
  • Anyone who is taking antiretroviral therapy (due to many drug interactions)
  • Women using other estrogen-containing products or herbal products that contain phytoestrogens
  • Known or suspected pregnancy, or desiring pregnancy in the next year

Additionally, NuvaRing® should not be used in women who currently have the following conditions:

  • Thrombophlebitis
  • A past history of deep vein thrombophlebitis or thromboembolic disorders
  • Cerebral vascular or coronary artery disease (current or history)
  • Valvular heart disease with thrombogenic complications
  • Severe hypertension
  • Diabetes with vascular involvement
  • Headaches with focal neurological symptoms
  • Major surgery in patients with prolonged immobilization
  • Known or suspected carcinoma of the breast or personal history of breast cancer
  • Carcinoma of the endometrium or other known or suspected estrogen dependent neoplasia
  • Undiagnosed abnormal genital bleeding
  • Cholestatic jaundice of pregnancy or jaundice with prior hormonal contraceptive use
  • Hepatic tumors (benign or malignant) or active live disease
  • Hypersensitivity to any components of NuvaRing®
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00475553

Locations
United States, Texas
Scott & White Hospital and Clinic
Temple, Texas, United States, 76508
Sponsors and Collaborators
Scott and White Hospital & Clinic
Organon
Investigators
Principal Investigator: Patricia Sulak, MD Scott and White Hospital & Clinic
  More Information

No publications provided

Responsible Party: Dr. Patricia Sulak, Scott and White Hospital
ClinicalTrials.gov Identifier: NCT00475553     History of Changes
Other Study ID Numbers: 50403
Study First Received: May 16, 2007
Last Updated: December 17, 2009
Health Authority: United States: Institutional Review Board

Keywords provided by Scott and White Hospital & Clinic:
spotting
PMS
nuvaring
birth control
pelvic pain
headache
mood swings
continuous use

Additional relevant MeSH terms:
Hemorrhage
Metrorrhagia
Pathologic Processes
Uterine Hemorrhage
Uterine Diseases
Genital Diseases, Female
Estradiol
Ethinyl Estradiol
3-keto-desogestrel
Estrogens
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on July 23, 2014