Management of Breakthrough Bleeding During Extended Therapy Use With NuvaRing®

Breakthrough Bleeding Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00475553
• Other study ID #: 50403
• Status: Completed
• Phase: N/A
• First received: May 16, 2007
• Last updated: December 17, 2009
• Start date: May 2006
• Est. completion date: May 2008

Study information

• Verified date: December 2009
• Source: Scott and White Hospital & Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 75
• Est. completion date: May 2008
• Est. primary completion date: May 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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®

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Breakthrough Bleeding
• Breakthrough Spotting
• Hemorrhage
• Metrorrhagia

Intervention

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.
• 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.

Locations

Country	Name	City	State
United States	Scott & White Hospital and Clinic	Temple	Texas

Sponsors (2)

Lead Sponsor	Collaborator
Scott and White Hospital & Clinic	Organon

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	a comparison of days and extent per day of bleeding and spotting within subjects for continuous use pattern of nuvaring.		6 months	No
Secondary	a comparison of choice to switch patterns or stick with randomized pattern for second phase of study (2nd 6 month interval).		6 months	No
Secondary	comparisons of all symptoms (pelvic pain, headaches, moodiness, and pain medication use) both within subjects during different treatment intervals and between subject groups.		12 months	No