Management of Breakthrough Bleeding During Extended Therapy Use With NuvaRing®

NCT00475553 | Completed

• 1 other identifier: 50403
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 1

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.

Conditions

Breakthrough Bleeding; Breakthrough Spotting

Keywords

spotting; PMS; nuvaring; birth control; pelvic pain; headache; mood swings; continuous use

Outcome Measures

Primary Outcomes (1)

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

  6 months

Secondary Outcomes (2)

• a comparison of choice to switch patterns or stick with randomized pattern for second phase of study (2nd 6 month interval).

  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.

  12 months

Study Arms (2)

Group 2

OTHER

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

Group 1

OTHER

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

Interventions

remove ring if bleeding or spotting occurs more than 5 days OTHER

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.

Also known as: etonogestrel/ethinyl estradiol

Group 2

If bleeding does not remove ring OTHER

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.

Also known as: nuvaring, etonogestrel/ethinyl estradiol, vaginal ring

Group 1

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Scott and White Hospital & Clinic: lead
• Organon: collaborator

Study Sites (1)

Scott & White Hospital and Clinic

Temple, Texas, 76508, United States

Location

MeSH Terms

Conditions

Metrorrhagia; Pelvic Pain; Headache

Interventions

etonogestrel; Ethinyl Estradiol; NuvaRing; Contraceptive Devices, Female

Condition Hierarchy (Ancestors)

Uterine Hemorrhage; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Pain; Neurologic Manifestations; Signs and Symptoms

Intervention Hierarchy (Ancestors)

Norpregnatrienes; Norpregnanes; Norsteroids; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estrogenic Steroids, Alkylated; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Contraceptive Devices; Equipment and Supplies

Study Officials

• Patricia Sulak, MD

  Scott and White Hospital & Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 16, 2007
• First Posted: May 21, 2007
• Study Start: May 1, 2006
• Primary Completion: May 1, 2008
• Study Completion: May 1, 2008
• Last Updated: December 18, 2009

Record last verified: 2009-12

Locations

US (1)