Drug InteractionsPhase 1NCT00709982
A Drug Interaction Study of Folic Acid and Oral Contraceptive Tablets Containing Norgestimate (NGM) /Ethinyl Estradiol (EE) in Healthy Women.
A Phase 1 study testing Norgestimate; Ethinyl Estradiol; Folic acid in people with Drug Interactions and Healthy, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
Trial summary
The purpose of the study is to assess the effect of folic acid administration on the blood level and the breakdown products of OC study drug (250 mcg norgestimate[NGM]/35 mcg Ethinyl Estradiol [EE]) tablets. The effect of study drug tablet intake on the blood level of folic acid is also determined. 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
- Drug Interactions, Healthy, Pharmacokinetics
- What is being tested?
- Norgestimate; Ethinyl Estradiol; Folic acid
- How many people
- 47 participants
- Where
- No sites listed yet
- Study dates
- May 2005to Jul 2005
- Phase
- Phase 1
- 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
- Healthy, nonpregnant, nonlactating, nonsmoking women, weighing at least 110 pounds
- With regular menstrual cycles
- A body mass index between 16 and 29.9 kg/m2
- And having a hematocrit of at least 36%
Who cannot join
- History or presence of disorders commonly accepted as contraindications to sex hormonal therapy including: thromboembolic disorders' cerebral vascular or coronary artery disease, chronic untreated hypertension, or migraines, benign or malignant liver tumor that developed during the use of OC
- Known or suspected estrogen-dependent neoplasia
- Presence of disorders commonly accepted as contraindications to combined OC including: undiagnosed abnormal vaginal bleeding, any neurovascular lesion of the eye or serious visual disturbance, or liver disease
- Intake any multivitamin or folic acid-containing supplements within 21 days before study admission
- Used a steroid hormone-containing intrauterine device within 3 months before study admission
- Used any medications that were known cytochrome P-450 enzyme inducers or inhibitors (e.g., St. John's Wort, cimetidine or rifampin), within 60 days before dosing
About this study
Official title: An Open-label Pharmacokinetic Drug Interaction Study of Folic Acid and 250 Mcg NGM/35 Mcg EE (ORTHO-CYCLEN) in Healthy Women..
The purpose of the study is to assess the effect of folic acid administration on the blood level and the breakdown products of OC study drug (250 mcg norgestimate[NGM]/35 mcg Ethinyl Estradiol [EE]) tablets. The effect of study drug tablet intake on the blood level of folic acid is also determined.
Read the detailed description
This is a single-center, open-label, pharmacokinetic drug interaction study between folic acid (1 mg) and study drug (250 mcg NGM/35 mcg EE) in 2 groups of at least 20 healthy women each. In Group 1, a single oral dose of 250 mcg NGM/35 mcg EE study drug was administered to the healthy volunteers at the study site on Days 1 and 17 and folic acid 1 mg was administered orally on Days 4 to 18; in Group 2, folic acid 1 mg was administered orally on Days 1 and 17 at the study site and 1 tablet of study drug was administered on Days 2 to 17. Blood samples were collected at specified times for 72 hours postdose on Days 1 and 17 for the healthy volunteers in Group 1 for determination of blood levels of norelgestromin (NGMN), and norgestrel (NG) [the active breakdown product of NGM], and EE. For the healthy volunteers in Group 2, blood samples were collected for 24 hours after the folic acid dose on Days 1 and 17 for determination of plasma levels of total folates. Safety was evaluated based on the following: the incidence, type and severity of adverse events; clinical laboratory tests; vital sign and electrocardiogram (ECGs) measurements; and physical examinations. Oral temperature, pulse, respiratory rate, and sitting blood pressure (BP) were taken before dosing on Days 1 and 17. For Group 1, measurements were taken before and at least 15 minutes after the 24-hour (Days 2 and 18), 48-hour (Days 3 and 19), and 72-hour (Day 4) pharmacokinetic blood draw; and at study completion (Day 20) or early withdrawal. For Group 2, measurements were taken before and at least 15 minutes after the 24-hour pharmacokinetic blood draw on Days 2 and 18; and at study completion (Day 18) or early withdrawal. Physical and gynecologic examinations and 12-lead ECGs were performed at screening and at study completion or early withdrawal. Blood samples for blood chemistry, hematology, and urine samples for urinalysis were collected at the screening visit and at the follow-up visit or early withdrawal.
Oral contraceptives tablet (250 mcg NGM/35 mcg EE); Folic acid tablet (1 mg). In Group 1, a single oral dose of (250 mcg NGM/35 mcg EE) study drug was administered on Days 1 and 17 and folic acid 1 mg was administered orally on Days 4 to 18; in Group 2, folic acid 1 mg was administered orally on Days 1 and 17 and 1 tablet of study drug was administered on Days 2 to 17. Study drugs were taken with 240 mL (8 oz) of water at approximately 8:00 a.m.
- Conditions
- Drug Interactions, Healthy, Pharmacokinetics
- Being tested
- Norgestimate; Ethinyl Estradiol; Folic acid
- Keywords
- Norgestimate, Contraceptives, Oral, Ortho-Cyclen, Folic Acid, Ethinyl Estradiol
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Norgestimate; Ethinyl Estradiol; Folic acidDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluate the pharmacokinetic drug interaction between folic acid and the study drug (250 mcg NGM and 35 mcg EE) as measured by the pharmacokinetics of the active breakdown product of NGM, norelgestromin (NGMN), and EE.
Secondary outcomes (1)
Measure the pharmacokinetics of the active metabolite of NGM, norgestrel (NG). Evaluate the effect of the study drug on the pharmacokinetics of folic acid. Assess the safety.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Jul 2008 (estimated)
- Study startMay 2005
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Drug InteractionsStudies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 47 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial, Study director, Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00709982
- Sponsor's protocol ID
- CR002380
- Status last verified
- Apr 2010
- First submitted
- 30 Jun 2008
- Last updated
- 8 Jun 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label Pharmacokinetic Drug Interaction Study of Folic Acid and 250 Mcg NGM/35 Mcg EE (ORTHO-CYCLEN) in Healthy Women..
- ClinicalTrials.gov ID
- NCT00709982
- Acronym / sponsor ID
- CR002380
- Conditions
- Drug Interactions, Healthy, Pharmacokinetics
- Keywords
- Norgestimate, Contraceptives, Oral, Ortho-Cyclen, Folic Acid, Ethinyl Estradiol
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 47 participants (actual)
- Lead sponsor
- Johnson & Johnson Pharmaceutical Research & Development, L.L.C.Industry (pharma, biotech, devices)
- Study start
- May 2005
- Study completion
- Jul 2005 (actual)
- First posted
- 3 Jul 2008 (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 the study is to assess the effect of folic acid administration on the blood level and the breakdown products of OC study drug (250 mcg norgestimate[NGM]/35 mcg Ethinyl Estradiol [EE]) tablets. The effect of study drug tablet intake on the blood level of folic acid is also determined.
Detailed description
This is a single-center, open-label, pharmacokinetic drug interaction study between folic acid (1 mg) and study drug (250 mcg NGM/35 mcg EE) in 2 groups of at least 20 healthy women each. In Group 1, a single oral dose of 250 mcg NGM/35 mcg EE study drug was administered to the healthy volunteers at the study site on Days 1 and 17 and folic acid 1 mg was administered orally on Days 4 to 18; in Group 2, folic acid 1 mg was administered orally on Days 1 and 17 at the study site and 1 tablet of study drug was administered on Days 2 to 17. Blood samples were collected at specified times for 72 hours postdose on Days 1 and 17 for the healthy volunteers in Group 1 for determination of blood levels of norelgestromin (NGMN), and norgestrel (NG) [the active breakdown product of NGM], and EE. For the healthy volunteers in Group 2, blood samples were collected for 24 hours after the folic acid dose on Days 1 and 17 for determination of plasma levels of total folates. Safety was evaluated based on the following: the incidence, type and severity of adverse events; clinical laboratory tests; vital sign and electrocardiogram (ECGs) measurements; and physical examinations. Oral temperature, pulse, respiratory rate, and sitting blood pressure (BP) were taken before dosing on Days 1 and 17. For Group 1, measurements were taken before and at least 15 minutes after the 24-hour (Days 2 and 18), 48-hour (Days 3 and 19), and 72-hour (Day 4) pharmacokinetic blood draw; and at study completion (Day 20) or early withdrawal. For Group 2, measurements were taken before and at least 15 minutes after the 24-hour pharmacokinetic blood draw on Days 2 and 18; and at study completion (Day 18) or early withdrawal. Physical and gynecologic examinations and 12-lead ECGs were performed at screening and at study completion or early withdrawal. Blood samples for blood chemistry, hematology, and urine samples for urinalysis were collected at the screening visit and at the follow-up visit or early withdrawal.
Oral contraceptives tablet (250 mcg NGM/35 mcg EE); Folic acid tablet (1 mg). In Group 1, a single oral dose of (250 mcg NGM/35 mcg EE) study drug was administered on Days 1 and 17 and folic acid 1 mg was administered orally on Days 4 to 18; in Group 2, folic acid 1 mg was administered orally on Days 1 and 17 and 1 tablet of study drug was administered on Days 2 to 17. Study drugs were taken with 240 mL (8 oz) of water at approximately 8:00 a.m.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy, nonpregnant, nonlactating, nonsmoking women, weighing at least 110 pounds
- With regular menstrual cycles
- A body mass index between 16 and 29.9 kg/m2
- And having a hematocrit of at least 36%
Key exclusion criteria (6 listed)
- History or presence of disorders commonly accepted as contraindications to sex hormonal therapy including: thromboembolic disorders' cerebral vascular or coronary artery disease, chronic untreated hypertension, or migraines, benign or malignant liver tumor that developed during the use of OC
- Known or suspected estrogen-dependent neoplasia
- Presence of disorders commonly accepted as contraindications to combined OC including: undiagnosed abnormal vaginal bleeding, any neurovascular lesion of the eye or serious visual disturbance, or liver disease
- Intake any multivitamin or folic acid-containing supplements within 21 days before study admission
- Used a steroid hormone-containing intrauterine device within 3 months before study admission
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; Folic acid | Drug | – |
Primary outcome
Evaluate the pharmacokinetic drug interaction between folic acid and the study drug (250 mcg NGM and 35 mcg EE) as measured by the pharmacokinetics of the active breakdown product of NGM, norelgestromin (NGMN), and EE.
1 secondary outcome
Measure the pharmacokinetics of the active metabolite of NGM, norgestrel (NG). Evaluate the effect of the study drug on the pharmacokinetics of folic acid. Assess the safety.
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 8 Jun 2011.
- A drug interaction study of folic acid and oral contraceptive tablets containing norgestimate (250 mcg)/ethinyl estradiol (35 mcg) in healthy womenLink provided by the sponsor.
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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.
Johnson & Johnson Pharmaceutical Research and Development, L.L.C. Clinical Trial study director
Johnson & Johnson Pharmaceutical Research & Development, L.L.C.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Norgestimate; Ethinyl Estradiol; Folic acid in people with Drug Interactions and Healthy, run by Johnson & Johnson Pharmaceutical Research & Development, L.L.C..
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 4 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 8 Jun 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Evaluate the pharmacokinetic drug interaction between folic acid and the study drug (250 mcg NGM and 35 mcg EE) as measured by the pharmacokinetics of the active breakdown product of NGM, norelgestromin (NGMN), and EE.. 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 8 Jun 2011.