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Management of Breakthrough Bleeding During Extended Therapy Use With NuvaRing®

Primary Purpose

Breakthrough Bleeding, Breakthrough Spotting

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
remove ring if bleeding or spotting occurs more than 5 days
If bleeding does not remove ring
Sponsored by
Scott and White Hospital & Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breakthrough Bleeding focused on measuring spotting, PMS, nuvaring, birth control, pelvic pain, headache, mood swings, continuous use

Eligibility Criteria

18 Years - 45 Years (Adult)FemaleAccepts Healthy Volunteers

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®

Sites / Locations

  • Scott & White Hospital and Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Group 2

Group 1

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

a comparison of days and extent per day of bleeding and spotting within subjects for continuous use pattern of nuvaring.

Secondary Outcome Measures

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.

Full Information

First Posted
May 16, 2007
Last Updated
December 17, 2009
Sponsor
Scott and White Hospital & Clinic
Collaborators
Organon
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1. Study Identification

Unique Protocol Identification Number
NCT00475553
Brief Title
Management of Breakthrough Bleeding During Extended Therapy Use With NuvaRing®
Official Title
The Frequency and Management of Breakthrough Bleeding During Extended Therapy With the Transvaginal Contraceptive Ring
Study Type
Interventional

2. Study Status

Record Verification Date
December 2009
Overall Recruitment Status
Completed
Study Start Date
May 2006 (undefined)
Primary Completion Date
May 2008 (Actual)
Study Completion Date
May 2008 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Scott and White Hospital & Clinic
Collaborators
Organon

4. Oversight

Data Monitoring Committee
No

5. Study Description

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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breakthrough Bleeding, Breakthrough Spotting
Keywords
spotting, PMS, nuvaring, birth control, pelvic pain, headache, mood swings, continuous use

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group 2
Arm Type
Other
Arm Description
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.
Arm Title
Group 1
Arm Type
Other
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
remove ring if bleeding or spotting occurs more than 5 days
Other Intervention Name(s)
etonogestrel/ethinyl estradiol
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
If bleeding does not remove ring
Other Intervention Name(s)
nuvaring, etonogestrel/ethinyl estradiol, vaginal ring
Intervention Description
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.
Primary Outcome Measure Information:
Title
a comparison of days and extent per day of bleeding and spotting within subjects for continuous use pattern of nuvaring.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
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
Title
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

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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®
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Patricia Sulak, MD
Organizational Affiliation
Scott and White Hospital & Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Scott & White Hospital and Clinic
City
Temple
State/Province
Texas
ZIP/Postal Code
76508
Country
United States

12. IPD Sharing Statement

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Management of Breakthrough Bleeding During Extended Therapy Use With NuvaRing®

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