Clinical trial NCT00475553: 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
Overall status: COMPLETED
Phase: NA
Conditions: Breakthrough Bleeding
Breakthrough Spotting
Keywords: spotting
PMS
nuvaring
birth control
pelvic pain
headache
mood swings
continuous use
Lead sponsor: Scott and White Hospital & Clinic
Sponsor class: OTHER
Collaborators: name: Organon
First posted: 2007-05-21
Enrollment: 75
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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®

Primary outcomes:
measure: a comparison of days and extent per day of bleeding and spotting within subjects for continuous use pattern of nuvaring.
timeFrame: 6 months
Secondary outcomes:
measure: a comparison of choice to switch patterns or stick with randomized pattern for second phase of study (2nd 6 month interval).
timeFrame: 6 months
measure: comparisons of all symptoms (pelvic pain, headaches, moodiness, and pain medication use) both within subjects during different treatment intervals and between subject groups.
timeFrame: 12 months
Other outcomes:
Locations:
city: Temple
country: United States
facility: Scott & White Hospital and Clinic
state: Texas
Study officials:
affiliation: Scott and White Hospital & Clinic
name: Patricia Sulak, MD
role: PRINCIPAL_INVESTIGATOR
References: