Breakthrough BleedingNCT00475553
Management of Breakthrough Bleeding During Extended Therapy Use With NuvaRing®
A study testing remove ring if bleeding or spotting occurs more than 5 days and If bleeding does not remove ring in people with Breakthrough Bleeding and Breakthrough Spotting, run by Scott and White Hospital & Clinic at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breakthrough Bleeding, Breakthrough Spotting
- What is being tested?
- remove ring if bleeding or spotting occurs more than 5 days and If bleeding does not remove ring
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteUnited States
- Study dates
- May 2006to May 2008
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 21Show fewer
- 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®
Trial locations and contacts
1 site in 1 country.
United States1 site
Scott & White Hospital and Clinic
Temple, Texas, 76508
About this study
Official title: The Frequency and Management of Breakthrough Bleeding During Extended Therapy With the Transvaginal Contraceptive Ring
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.
Read the 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.
- Conditions
- Breakthrough Bleeding, Breakthrough Spotting
- Being tested
- remove ring if bleeding or spotting occurs more than 5 days, If bleeding does not remove ring
- Keywords
- spotting, PMS, nuvaring, birth control, pelvic pain, headache, mood swings, continuous use
- Medical subject headings
- Metrorrhagia, Pelvic Pain, Headache
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
remove ring if bleeding or spotting occurs more than 5 daysOther
Also called etonogestrel/ethinyl estradiol
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.
If bleeding does not remove ringOther
Also called nuvaring, etonogestrel/ethinyl estradiol, vaginal 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Other: If bleeding does not remove ring |
What is being measured
The primary outcome is the main question the study is designed to answer.
a comparison of days and extent per day of bleeding and spotting within subjects for continuous use pattern of nuvaring.
Measured: 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).
Measured: 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.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 May 2007 (estimated)
- Study startMay 2006
- Primary completionMay 2008
- Study completionMay 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breakthrough BleedingStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Scott and White Hospital & Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Organon
- Investigators
- Patricia Sulak, MD, Principal investigator, Scott and White Hospital & Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00475553
- Sponsor's protocol ID
- 50403
- Status last verified
- Dec 2009
- First submitted
- 16 May 2007
- Last updated
- 18 Dec 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Frequency and Management of Breakthrough Bleeding During Extended Therapy With the Transvaginal Contraceptive Ring
- ClinicalTrials.gov ID
- NCT00475553
- Acronym / sponsor ID
- 50403
- Conditions
- Breakthrough Bleeding, Breakthrough Spotting
- Keywords
- spotting, PMS, nuvaring, birth control, pelvic pain, headache, mood swings, continuous use
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Scott and White Hospital & ClinicUniversity, hospital or other
- Collaborators
- Organon
- Study start
- May 2006
- Primary completion
- May 2008 (actual)
- Study completion
- May 2008 (actual)
- First posted
- 21 May 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group 2 | Other | Other: remove ring if bleeding or spotting occurs more than 5 daysSubject 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. |
| Group 1 | Other | Other: If bleeding does not remove ringSubject 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (21 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| remove ring if bleeding or spotting occurs more than 5 daysAlso: etonogestrel/ethinyl estradiolBoth 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. | Other | Group 2 |
| If bleeding does not remove ringAlso: nuvaring, etonogestrel/ethinyl estradiol, vaginal ringSubject 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. | Other | Group 1 |
Primary outcome
a comparison of days and extent per day of bleeding and spotting within subjects for continuous use pattern of nuvaring.
Time frame: 6 months
2 secondary outcomes
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
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patricia Sulak, MD principal investigator
Scott and White Hospital & Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing remove ring if bleeding or spotting occurs more than 5 days and If bleeding does not remove ring in people with Breakthrough Bleeding and Breakthrough Spotting, run by Scott and White Hospital & Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Dec 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
a comparison of days and extent per day of bleeding and spotting within subjects for continuous use pattern of nuvaring. (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2009.