MetrorrhagiaPhase 2NCT00344383
An Open-Label Study Evaluating Breakthrough Bleeding and Spotting With Norgestimate/Ethinyl Estradiol Tablets Administered as an Extended Regimen
A Phase 2 study testing Norgestimate/Ethinyl Estradiol tablet 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 evaluate the bleeding profile of norgestimate/ethinyl estradiol, an oral contraceptive tablet, given in an extended 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?
- Norgestimate/Ethinyl Estradiol tablet
- Type of treatment
- Pill or oral medicine
- How many people
- 61 participants
- Where
- No sites listed yet
- Study dates
- Nov 2003to Jul 2004
- 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
- Subjects in good health as confirmed by medical history, physical exam, and PAP smear within the preceding six months
- Non-smokers, if between 35 and 45 years of age
- Patients who are not pregnant or lactating
- Had at least one normal menstrual period within 35 days prior to screening
- Completed their last term pregnancy at least 42 days prior to screening and had at least one normal menstrual period since the last pregnancy
- Must be post-menarcheal (have had at least one normal menstrual period) and pre-menopausal (having regular menstrual periods)
Who cannot join
- History or presence of disorders commonly accepted as contraindications to steroid hormonal therapy, eg, menopause, active or history of deep vein thrombophlebitis, thromboembolic disorders or hypercoagulation disorders, cerebral vascular or coronary artery disease, uncontrolled hypertension, or migraines with focal aura, benign or malignant liver tumor that developed during the use of oral contraceptives or estrogen-containing products
- carcinoma of any body system, diabetes mellitus with vascular involvement, known or suspected estrogen-dependent neoplasia, cholestatic jaundice, undiagnosed abnormal vaginal bleeding, neurovascular lesion of the eye, clinically relevant impairment of liver function, liver disease or renal disease
- absence of cyclic bleeding for at least three months, recent history of alcohol or other substance abuse
- significant depression or psychiatric disease that would result in an unreliable patients
- any subject deemed by the investigator to have questionable reliability in her ability to comply with the protocol and provide accurate information.
About this study
Official title: An Open-Label Study Evaluating the Bleeding Profile of Ortho Tri-Cyclen Lo (Norgestimate/Ethinyl Estradiol) Administered as an Extended Regimen
The purpose of this study is to evaluate the bleeding profile of norgestimate/ethinyl estradiol, an oral contraceptive tablet, given in an extended regimen
Read the detailed description
This is an open-label study evaluating the bleeding profile of norgestimate/ethinyl estradiol tablets administered as an extended regimen (84 consecutive days of active tablets followed by seven days medication free) following a traditional regimen of two 28-day cycles (21 days of active tablets, followed by seven days of placebo tablets) of norgestimate/ethinyl estradiol tablets. All patients will receive norgestimate/ethinyl estradiol tablets in a traditional regimen for two 28-day cycles. Following the Traditional Treatment Phase, all patients will receive norgestimate/ethinyl estradiol tablets in an Extended Regimen Treatment Phase, consisting of 84 days of treatment with norgestimate/ethinyl estradiol tablets. Safety evaluations include physical examinations, adverse event reporting and vital signs. The hypothesis of the study is that a triphasic extended regimen would not result in breakthrough bleeding and spotting when the progestin dose drops. Traditional Regimen: two 28 day cycles of norgestimate 180 mcg daily for 1 week, 215 mcg daily for 1 week, 250 mcg daily for 1 week, placebo daily for 1 week. Extended Regimen: four uninterrupted cycles of norgestimate 180 mcg daily for 1 week, 215 mcg daily for 1 week, 250 mcg daily for 1 week, 1 week medication-free. In both Treatment Regimens patients receive ethinyl estradiol 25 mcg in each active tablet. The study is 147 days, Traditional days 1-56 and Extended days 57-147
- Conditions
- Metrorrhagia
- Being tested
- Norgestimate/Ethinyl Estradiol tablet
- Keywords
- oral contraceptive, 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.
Norgestimate/Ethinyl Estradiol tabletDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary efficacy variables include the number of breakthrough bleeding and/or spotting days during the extended regimen treatment phase and the number of breakthrough bleeding days during the extended regimen treatment phase.
Secondary outcomes (1)
Secondary efficacy variables include the number of bleeding and/or spotting days, number of bleeding days, number of bleeding and/or spotting episodes, and number of bleeding episodes during both treatment regimens
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jun 2006 (estimated)
- Study startNov 2003
- Study completionJul 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 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
- NCT00344383
- Sponsor's protocol ID
- CR008344
- Status last verified
- Mar 2011
- First submitted
- 23 Jun 2006
- Last updated
- 4 Mar 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Mar 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Study Evaluating the Bleeding Profile of Ortho Tri-Cyclen Lo (Norgestimate/Ethinyl Estradiol) Administered as an Extended Regimen
- ClinicalTrials.gov ID
- NCT00344383
- Acronym / sponsor ID
- CR008344
- Conditions
- Metrorrhagia
- Keywords
- oral contraceptive, breakthrough bleeding, spotting
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.Industry (pharma, biotech, devices)
- Study start
- Nov 2003
- Study completion
- Jul 2004 (actual)
- First posted
- 26 Jun 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 evaluate the bleeding profile of norgestimate/ethinyl estradiol, an oral contraceptive tablet, given in an extended regimen
Detailed description
This is an open-label study evaluating the bleeding profile of norgestimate/ethinyl estradiol tablets administered as an extended regimen (84 consecutive days of active tablets followed by seven days medication free) following a traditional regimen of two 28-day cycles (21 days of active tablets, followed by seven days of placebo tablets) of norgestimate/ethinyl estradiol tablets. All patients will receive norgestimate/ethinyl estradiol tablets in a traditional regimen for two 28-day cycles. Following the Traditional Treatment Phase, all patients will receive norgestimate/ethinyl estradiol tablets in an Extended Regimen Treatment Phase, consisting of 84 days of treatment with norgestimate/ethinyl estradiol tablets. Safety evaluations include physical examinations, adverse event reporting and vital signs. The hypothesis of the study is that a triphasic extended regimen would not result in breakthrough bleeding and spotting when the progestin dose drops. Traditional Regimen: two 28 day cycles of norgestimate 180 mcg daily for 1 week, 215 mcg daily for 1 week, 250 mcg daily for 1 week, placebo daily for 1 week. Extended Regimen: four uninterrupted cycles of norgestimate 180 mcg daily for 1 week, 215 mcg daily for 1 week, 250 mcg daily for 1 week, 1 week medication-free. In both Treatment Regimens patients receive ethinyl estradiol 25 mcg in each active tablet. The study is 147 days, Traditional days 1-56 and Extended days 57-147
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Subjects in good health as confirmed by medical history, physical exam, and PAP smear within the preceding six months
- Non-smokers, if between 35 and 45 years of age
- Patients who are not pregnant or lactating
- Had at least one normal menstrual period within 35 days prior to screening
- Completed their last term pregnancy at least 42 days prior to screening and had at least one normal menstrual period since the last pregnancy
Key exclusion criteria (5 listed)
- History or presence of disorders commonly accepted as contraindications to steroid hormonal therapy, eg, menopause, active or history of deep vein thrombophlebitis, thromboembolic disorders or hypercoagulation disorders, cerebral vascular or coronary artery disease, uncontrolled hypertension, or migraines with focal aura, benign or malignant liver tumor that developed during the use of oral contraceptives or estrogen-containing products
- carcinoma of any body system, diabetes mellitus with vascular involvement, known or suspected estrogen-dependent neoplasia, cholestatic jaundice, undiagnosed abnormal vaginal bleeding, neurovascular lesion of the eye, clinically relevant impairment of liver function, liver disease or renal disease
- absence of cyclic bleeding for at least three months, recent history of alcohol or other substance abuse
- significant depression or psychiatric disease that would result in an unreliable patients
- any subject deemed by the investigator to have questionable reliability in her ability to comply with the protocol and provide accurate information.
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 |
|---|---|---|
| Norgestimate/Ethinyl Estradiol tablet | Drug | – |
Primary outcome
The primary efficacy variables include the number of breakthrough bleeding and/or spotting days during the extended regimen treatment phase and the number of breakthrough bleeding days during the extended regimen treatment phase.
1 secondary outcome
Secondary efficacy variables include the number of bleeding and/or spotting days, number of bleeding days, number of bleeding and/or spotting episodes, and number of bleeding episodes during both treatment regimens
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 4 Mar 2011.
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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 Norgestimate/Ethinyl Estradiol tablet 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 6 inclusion and 5 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 4 Mar 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 include the number of breakthrough bleeding and/or spotting days during the extended regimen treatment phase and the number of breakthrough bleeding days during the extended regimen treatment phase.. 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 4 Mar 2011.