Management of Breakthrough Bleeding During Extended Therapy Use With NuvaRing®
Completed · Not applicable
Conditions studied: Breakthrough Bleeding, Breakthrough Spotting
In brief
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.
Key facts
- Study ID
- NCT00475553
- Run by
- Scott and White Hospital & Clinic
- People needed
- 75
- Starts
- 2006-05-01
- Expected to finish
- 2008-05-01
- Last updated by the study team
- 2009-12-18
Who can join
Age: 18 and older, up to 45. Sex: female. Healthy volunteers: accepted.
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
- 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®
Where it is running
- Scott & White Hospital and Clinic — Temple, Texas, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.