Management of Breakthrough Bleeding During Extended Therapy Use With NuvaRing® - Full Text View

Sponsors and Collaborators:	Scott and White Hospital & Clinic Organon
Information provided by:	Scott and White Hospital & Clinic
ClinicalTrials.gov Identifier:	NCT00475553

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

MedlinePlus related topics: Headache Pelvic Pain

Drug Information available for: Estradiol Estradiol 3-benzoate Ethinyl estradiol Polyestradiol phosphate Etonogestrel Depogen Estradiol dipropionate Estradiol cypionate Estradiol valerate Estradiol acetate

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study
Official Title:	The Frequency and Management of Breakthrough Bleeding During Extended Therapy With the Transvaginal Contraceptive Ring

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.
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.

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.

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.

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

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 and Clinic

More Information

No publications provided

Responsible Party:	Scott and White Hospital ( Dr. Patricia Sulak )
Study ID Numbers:	50403
Study First Received:	May 16, 2007
Last Updated:	May 20, 2008
ClinicalTrials.gov Identifier:	NCT00475553 History of Changes
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

Study placed in the following topic categories:

Estrogens
Metrorrhagia
Uterine Hemorrhage
Contraceptive Agents
Hormone Antagonists
Estradiol valerate
Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Ethinyl Estradiol
Uterine Diseases
Pain

Estradiol 17 beta-cypionate
Hemorrhage
Hormones
Estradiol
Genital Diseases, Female
Desogestrel
Pelvic Pain
Estradiol 3-benzoate
Headache
Polyestradiol phosphate
3-keto-desogestrel

Additional relevant MeSH terms:

Estrogens
Metrorrhagia
Uterine Hemorrhage
Contraceptive Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Hormones, Hormone Substitutes, and Hormone Antagonists
Uterine Diseases
Ethinyl Estradiol

Reproductive Control Agents
Hemorrhage
Hormones
Pharmacologic Actions
Genital Diseases, Female
Pathologic Processes
Therapeutic Uses
3-keto-desogestrel

ClinicalTrials.gov processed this record on May 07, 2009