MetrorrhagiaPhase 2NCT00320580
An Open-Label Study to Compare the Bleeding Profile of Norelgestromin/Ethinyl Estradiol in an Extended Regimen to Norelgestromin/Ethinyl Estradiol Given in a Traditional Regimen
A Phase 2 study testing norelgestromin/ethinyl estradiol in people with Metrorrhagia, run by McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc..
Trial summary
The purpose of this study is to compare the bleeding profile of norelgestromin/ethinyl estradiol given in an extended continuous regimen to norelgestromin/ethinyl estradiol given in a traditional cyclic regimen 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
- Metrorrhagia
- What is being tested?
- norelgestromin/ethinyl estradiol
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 239 participants
- Where
- No sites listed yet
- Study dates
- Start not givento Mar 2003
- Phase
- Phase 2
- 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
- Patients in good health as confirmed by medical history
- not pregnant as demonstrated by negative urine pregnancy test
- completed their last term pregnancy at least 42 days prior to Screening and at least one normal menstrual period since last pregnancy
- not lactating
- post-menarcheal and pre-menopausal
Who cannot join
- History or presence of disorders commonly accepted as contraindications to steroid hormonal therapy including but not limited to the following - active or history of deep vein thrombophlebitis or thromboembolytic disorders or hypercoagulation disorders, cerebral vascular or coronary artery disease, uncontrolled hypertension, or migraines with focal aura, benign or malignant liver tumor which developed during the use of oral contraceptives or estrogen-containing products
- treatment with continuous oral contraception within three months of study
- previous use of contraceptive patch including norelgestromin/ethinyl estradiol
- patients who are amenorrheic (abnormal suppression or absence of menstruation)
- recent history of alcohol or substance abuse
- skin conditions resulting in oily, irritated or damaged skin at potential sites of application
About this study
Official title: A Randomized, Open-Label, Multicenter Study Comparing the Bleeding Profile of Ortho Evra (Norelgestromin/Ethinyl Estradiol) Continuous Regimen vs. Ortho Evra Cyclic Regimen
The purpose of this study is to compare the bleeding profile of norelgestromin/ethinyl estradiol given in an extended continuous regimen to norelgestromin/ethinyl estradiol given in a traditional cyclic regimen
Read the detailed description
Norelgestromin/ethinyl estradiol is a contraceptive patch shown to be safe and effective for the prevention of pregnancy. The usual treatment regimen is three consecutive seven-day patches followed by one patch-free week. This cyclic method is followed in order to mimic the 28-day menstrual cycle. An extended contraceptive regimen (administration of active hormones for greater than 21 days) of oral contraceptives is a common practice among women wishing to delay or prevent withdrawal bleeding for reasons such as athletic participation or going on vacation. In addition to the convenience of reducing the frequency of withdrawal bleeds, elimination of the hormone-free interval reportedly reduces many menstrually-related symptoms (headaches, pelvic pain, breast tenderness, bloating, swelling) that occur at a greater frequency during the hormone-free interval than during the rest of the cycle. Headache is one of the most common adverse effects associated with hormonal contraceptive use. Studies have demonstrated that headaches were reduced in subjects using extended intervals of active hormone. However, one of the main side effects reported with extended regimens is breakthrough bleeding and/or spotting. Compared to cyclic regimens, extended oral contraceptive use may be associated with an increased incidence of breakthrough bleeding and spotting, especially during the first few months of use. This is a randomized (patients are assigned different treatments based on chance), open-label, multicenter study comparing the bleeding profile of norelgestromin/ethinyl estradiol patch continuous regimen to norelgestromin/ethinyl estradiol patch cyclic regimen. Safety evaluations include adverse event reporting, physical examinations, blood levels, and vital signs. The hypothesis of the study is that norelgestromin/ethinyl estradiol in an extended regimen of 84 days of active hormone would result in fewer days and episodes of bleeding compared to a traditional cyclic regimen of norelgestromin/ethinyl estradiol. Patients receive norelgestromin/ethinyl estradiol patches in a plastic sleeve. In the extended regimen patches will be applied weekly for 12 consecutive weeks followed by one week patch-free and then another three consecutive weeks of weekly patch applications. In the cyclic regimen patches will be applied for four consecutive cycles where each cycle consists of three weekly patch applications followed by one week patch-free. The total duration of treatment period is 112 days for each regimen.
- Conditions
- Metrorrhagia
- Being tested
- norelgestromin/ethinyl estradiol
- Keywords
- Metrorrhagia, oral contraception, breakthrough bleeding, spotting
- Medical subject headings
- Metrorrhagia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
norelgestromin/ethinyl estradiolDrug
| Study group | Role | What they receive |
|---|---|---|
| 001 | Experimental | norelgestromin/ethinyl estradiol Receives: Drug: norelgestromin/ethinyl estradiol |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy variables are the total number bleeding and/or spotting days during the 84-day reference period and the number of bleeding and/or spotting episodes during the 84-day reference period.
Secondary outcomes (1)
Secondary efficacy variables include the number of breakthrough bleeding and/or spotting days per 28-day interval, the number of breakthrough bleeding days per 28-day interval, time to first bleeding and/or spotting, duration of menses.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2006 (estimated)
- Study completionMar 2003
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for MetrorrhagiaStudies 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- McNeil Consumer & Specialty Pharmaceuticals, a Division of Mc Neil-PPC, Inc. Clinical Trial, Study director, McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00320580
- Sponsor's protocol ID
- CR008335
- Status last verified
- Jun 2011
- First submitted
- 28 Apr 2006
- Last updated
- 1 Jul 2011
- Results posted
- No
Publications
Stewart FH, Kaunitz AM, Laguardia KD, Karvois DL, Fisher AC, Friedman AJ. Extended use of transdermal norelgestromin/ethinyl estradiol: a randomized trial. Obstet Gynecol. 2005 Jun;105(6):1389-96. doi: 10.1097/01.AOG.0000160430.61799.f6.
PubMed 15932834LaGuardia KD, Fisher AC, Bainbridge JD, LoCoco JM, Friedman AJ. Suppression of estrogen-withdrawal headache with extended transdermal contraception. Fertil Steril. 2005 Jun;83(6):1875-7. doi: 10.1016/j.fertnstert.2004.12.048.
PubMed 15950671
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Open-Label, Multicenter Study Comparing the Bleeding Profile of Ortho Evra (Norelgestromin/Ethinyl Estradiol) Continuous Regimen vs. Ortho Evra Cyclic Regimen
- ClinicalTrials.gov ID
- NCT00320580
- Acronym / sponsor ID
- CR008335
- Conditions
- Metrorrhagia
- Keywords
- Metrorrhagia, oral contraception, breakthrough bleeding, spotting
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.Industry (pharma, biotech, devices)
- Study completion
- Mar 2003 (actual)
- First posted
- 3 May 2006 (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 study is to compare the bleeding profile of norelgestromin/ethinyl estradiol given in an extended continuous regimen to norelgestromin/ethinyl estradiol given in a traditional cyclic regimen
Detailed description
Norelgestromin/ethinyl estradiol is a contraceptive patch shown to be safe and effective for the prevention of pregnancy. The usual treatment regimen is three consecutive seven-day patches followed by one patch-free week. This cyclic method is followed in order to mimic the 28-day menstrual cycle. An extended contraceptive regimen (administration of active hormones for greater than 21 days) of oral contraceptives is a common practice among women wishing to delay or prevent withdrawal bleeding for reasons such as athletic participation or going on vacation. In addition to the convenience of reducing the frequency of withdrawal bleeds, elimination of the hormone-free interval reportedly reduces many menstrually-related symptoms (headaches, pelvic pain, breast tenderness, bloating, swelling) that occur at a greater frequency during the hormone-free interval than during the rest of the cycle. Headache is one of the most common adverse effects associated with hormonal contraceptive use. Studies have demonstrated that headaches were reduced in subjects using extended intervals of active hormone. However, one of the main side effects reported with extended regimens is breakthrough bleeding and/or spotting. Compared to cyclic regimens, extended oral contraceptive use may be associated with an increased incidence of breakthrough bleeding and spotting, especially during the first few months of use. This is a randomized (patients are assigned different treatments based on chance), open-label, multicenter study comparing the bleeding profile of norelgestromin/ethinyl estradiol patch continuous regimen to norelgestromin/ethinyl estradiol patch cyclic regimen. Safety evaluations include adverse event reporting, physical examinations, blood levels, and vital signs. The hypothesis of the study is that norelgestromin/ethinyl estradiol in an extended regimen of 84 days of active hormone would result in fewer days and episodes of bleeding compared to a traditional cyclic regimen of norelgestromin/ethinyl estradiol. Patients receive norelgestromin/ethinyl estradiol patches in a plastic sleeve. In the extended regimen patches will be applied weekly for 12 consecutive weeks followed by one week patch-free and then another three consecutive weeks of weekly patch applications. In the cyclic regimen patches will be applied for four consecutive cycles where each cycle consists of three weekly patch applications followed by one week patch-free. The total duration of treatment period is 112 days for each regimen.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 001 | Experimental | Drug: norelgestromin/ethinyl estradiolnorelgestromin/ethinyl estradiol |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients in good health as confirmed by medical history
- not pregnant as demonstrated by negative urine pregnancy test
- completed their last term pregnancy at least 42 days prior to Screening and at least one normal menstrual period since last pregnancy
- not lactating
- post-menarcheal and pre-menopausal
Key exclusion criteria (6 listed)
- History or presence of disorders commonly accepted as contraindications to steroid hormonal therapy including but not limited to the following - active or history of deep vein thrombophlebitis or thromboembolytic disorders or hypercoagulation disorders, cerebral vascular or coronary artery disease, uncontrolled hypertension, or migraines with focal aura, benign or malignant liver tumor which developed during the use of oral contraceptives or estrogen-containing products
- treatment with continuous oral contraception within three months of study
- previous use of contraceptive patch including norelgestromin/ethinyl estradiol
- patients who are amenorrheic (abnormal suppression or absence of menstruation)
- recent history of alcohol or substance abuse
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 |
|---|---|---|
| norelgestromin/ethinyl estradiol | Drug | 001 |
Primary outcome
The primary efficacy variables are the total number bleeding and/or spotting days during the 84-day reference period and the number of bleeding and/or spotting episodes during the 84-day reference period.
1 secondary outcome
Secondary efficacy variables include the number of breakthrough bleeding and/or spotting days per 28-day interval, the number of breakthrough bleeding days per 28-day interval, time to first bleeding and/or spotting, duration of menses.
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 1 Jul 2011.
- Results publication: PubMed 15932834Stewart FH, Kaunitz AM, Laguardia KD, Karvois DL, Fisher AC, Friedman AJ. Extended use of transdermal norelgestromin/ethinyl estradiol: a randomized trial. Obstet Gynecol. 2005 Jun;105(6):1389-96. doi: 10.1097/01.AOG.0000160430.61799.f6.
- Results publication: PubMed 15950671LaGuardia KD, Fisher AC, Bainbridge JD, LoCoco JM, Friedman AJ. Suppression of estrogen-withdrawal headache with extended transdermal contraception. Fertil Steril. 2005 Jun;83(6):1875-7. doi: 10.1016/j.fertnstert.2004.12.048.
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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.
McNeil Consumer & Specialty Pharmaceuticals, a Division of Mc Neil-PPC, Inc. Clinical Trial study director
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing norelgestromin/ethinyl estradiol in people with Metrorrhagia, run by McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc..
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 5 inclusion and 6 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 1 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
The primary efficacy variables are the total number bleeding and/or spotting days during the 84-day reference period and the number of bleeding and/or spotting episodes during the 84-day reference period.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00320580, which also lists 2 linked publications.
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 1 Jul 2011.