Rheumatoid ArthritisPhase 3NCT01044498
A Study of Tocilizumab in Combination With an Oral Contraceptive in Patients With Rheumatoid Arthritis
A Phase 3 study testing Tocilizumab and Ortho-Novum® 1/35 in people with Rheumatoid Arthritis, run by Hoffmann-La Roche at 6 sites in United States.
Trial summary
This open-label, randomized, cross-over study evaluated the effect of tocilizumab (TCZ) on the pharmacokinetics and pharmacodynamics of a common oral contraceptive (OC) in female patients with active rheumatoid arthritis (RA) and in healthy female volunteers of child bearing age. Read more about this study
- Who is it for?
- Ages 18 to 44 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- Tocilizumab and Ortho-Novum® 1/35
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 46 participants
- Where
- 6 sitesUnited States
- Study dates
- Dec 2009to Feb 2012
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 44 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult patients with child bearing potential, 18-44 years of age.
- Rheumatoid arthritis (RA) for over 6 months duration.
- On oral contraceptive without interruption for at least 3 months with normal cycle control.
- Treatment with disease-modifying anth-rheumatic drugs (DMARD) for at least 12 weeks prior to study start.
- Body weight < 150 kg.
Who cannot join
- Functional class IV rheumatoid arthritis (American College of Rheumatology [ACR] classification).
- History of amenorrhea (unrelated to pregnancy).
- History or current inflammatory joint disease other than RA.
- Rheumatic autoimmune disease other than RA.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
United States6 sites
Study site
Beverly Hills, California, 90211
Study site
Duncansville, Pennsylvania, 16635
Study site
Little Rock, Arkansas, 72212
Study site
Ormond Beach, Florida, 32174
Study site
Port Orange, Florida, 32127
Study site
San Antonio, Texas, 78222
About this study
Official title: An Open-label, Multi-center, One Sequence Cross-over Drug Interaction Study to Investigate the Effect of Tocilizumab (TCZ, RO4877533) on the Pharmacokinetics and Pharmacodynamics of an Oral Contraceptive (OC) in Female Patients With Active Rheumatoid Arthritis (RA)
This open-label, randomized, cross-over study evaluated the effect of tocilizumab (TCZ) on the pharmacokinetics and pharmacodynamics of a common oral contraceptive (OC) in female patients with active rheumatoid arthritis (RA) and in healthy female volunteers of child bearing age. The RA patients received OC in combination with TCZ, whereas the healthy volunteers received OC only. The RA patients received OC in 3 cycles of 21 days each; TCZ 8 mg/kg was administered once as an intravenous infusion on the first day of Cycle 2. The healthy volunteers received OC for only one 21-day cycle.
- Conditions
- Rheumatoid Arthritis
- Being tested
- Tocilizumab, Ortho-Novum® 1/35
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TocilizumabDrug
Also called RoActemra, Actemra
Tocilizumab 8 mg/kg was administered in a single 1-hour infusion on Day 1 of Cycle 2.
Ortho-Novum® 1/35Drug
Each Ortho-Novum® 1/35 tablet contained 1 mg of norethindrone and 0.035 mg of ethinyl estradiol.
| Study group | Role | What they receive |
|---|---|---|
| Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1) | Experimental | Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously. Receives: Drug: Tocilizumab; Drug: Ortho-Novum® 1/35 |
| Ortho-Novum® 1/35 (Group 2) | Other | Healthy volunteers received Ortho-Novum® 1/35 tablets daily on Days 1-21 of one 28-day cycle. Receives: Drug: Ortho-Novum® 1/35 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Progesterone Level
Blood samples were collected prior to the administration of Ortho-Novum® 1/35 on Day 21 of each cycle. Serum levels of progesterone were quantitatively determined using the ADVIA Centaur and ADVIA Centaur XP systems (Siemens Healthcare Diagnostics Inc., Tarrytown, NY, USA). The assay was a competitive immunoassay using direct chemiluminescent technology.
Measured: Day 21 of Cycles 1-3 for Group 1 and Day 21 of Cycle 1 for Group 2
Secondary outcomes (13)
Maximum Observed Plasma Concentration (Cmax) of Ethinyl Estradiol and Norethindrone
Blood samples were collected prior to and at 0.5, 1, 1.5, 2, 3, 5, 8, 12 and 24 hours after administration of Ortho-Novum® 1/35 on Day 7 of each cycle. The concentrations of ethinyl estradiol and norethindrone were determined in human heparinized plasma according to a validated gas chromatography coupled to mass spectrometry (GC-MS) method. The maximum observed plasma concentration (Cmax) was derived from the plasma concentrations using a non-compartmental method with the software WinNonlin Enterprise version 5.2 (or above).
Measured: Day 7 of Cycles 1-3 for Group 1 and Day 7 of Cycle 1 for Group 2
Time to Reach the Maximum Plasma Concentration (Tmax) of Ethinyl Estradiol and Norethindrone
Blood samples were collected prior to and at 0.5, 1, 1.5, 2, 3, 5, 8, 12 and 24 hours after administration of Ortho-Novum® 1/35 on Day 7 of each cycle. The concentrations of ethinyl estradiol and norethindrone were determined in human heparinized plasma according to a validated gas chromatography coupled to mass spectrometry (GC-MS) method. The time to reach the maximum plasma concentration (Tmax) was derived from the plasma concentrations using a non-compartmental method with the software WinNonlin Enterprise version 5.2 (or above).
Measured: Day 7 of Cycles 1-3 for Group 1 and Day 7 of Cycle 1 for Group 2
Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC0-24) of Ethinyl Estradiol and Norethindrone
Blood samples were collected prior to and at 0.5, 1, 1.5, 2, 3, 5, 8, 12 and 24 hours after administration of Ortho-Novum® 1/35 on Day 7 of each cycle. The concentrations of ethinyl estradiol and norethindrone were determined in human heparinized plasma according to a validated gas chromatography coupled to mass spectrometry (GC-MS) method. The area under the plasma concentration-time curve from 0 to 24 hours (AUC0-24) was derived from the plasma concentrations using a non-compartmental method and computed using the linear trapezoidal rule with the software WinNonlin Enterprise version 5.2 (or above).
Measured: Day 7 of Cycles 1-3 for Group 1 and Day 7 of Cycle 1 for Group 2
Terminal Half-life (t½) of Ethinyl Estradiol and Norethindrone
Blood samples were collected prior to and at 0.5, 1, 1.5, 2, 3, 5, 8, 12 and 24 hours after administration of Ortho-Novum® 1/35 on Day 7 of each cycle. The concentrations of ethinyl estradiol and norethindrone were determined in human heparinized plasma according to a validated gas chromatography coupled to mass spectrometry (GC-MS) method. The terminal half-life (t½) was derived from the plasma concentrations using a non-compartmental method with the software WinNonlin Enterprise version 5.2 (or above).
Measured: Day 7 of Cycles 1-3 for Group 1 and Day 7 of Cycle 1 for Group 2
Apparent Oral Clearance (CL/F) of Ethinyl Estradiol and Norethindrone
Blood samples were collected prior to and at 0.5, 1, 1.5, 2, 3, 5, 8, 12 and 24 hours after administration of Ortho-Novum® 1/35 on Day 7 of each cycle. The concentrations of ethinyl estradiol and norethindrone were determined in human heparinized plasma according to a validated gas chromatography coupled to mass spectrometry (GC-MS) method. The apparent oral clearance (CL/F) was derived from the plasma concentrations using a non-compartmental method and computed as dose/AUC0-24 with the software WinNonlin Enterprise version 5.2 (or above).
Measured: Day 7 of Cycles 1-3 for Group 1 and Day 7 of Cycle 1 for Group 2
Maximum Observed Serum Concentration (Cmax) of Tocilizumab
Blood samples were collected pre-dose and at the end of infusion of tocilizumab on Day 1 of Cycle 2. Additional blood samples were collected on Days 2, 3, 5, 7, 12, 14, 21 of Cycle 2, and Days 1, 7, and 21 of Cycle 3. The concentration of tocilizumab was determined in serum samples using a validated enzyme-linked immunosorbent assay (ELISA). The maximum observed plasma concentration (Cmax) was derived from the serum concentrations using a non-compartmental method with the software WinNonlin Enterprise version 5.2 (or above).
Measured: From Day 1 of Cycle 2 to Day 21 of Cycle 3 for Group 1
Time to Reach Maximum Serum Concentration (Tmax) of Tocilizumab
Blood samples were collected pre-dose and at the end of infusion of tocilizumab on Day 1 of Cycle 2. Additional blood samples were collected on Days 2, 3, 5, 7, 12, 14, 21 of Cycle 2, and Days 1, 7, and 21 of Cycle 3. The concentration of tocilizumab was determined in serum samples using a validated ELISA. The time to reach maximum serum concentration was derived from the serum concentrations using a non-compartmental method with the software WinNonlin Enterprise version 5.2 (or above).
Measured: From Day 1 of Cycle 2 to Day 21 of Cycle 3 for Group 1
Area Under the Serum Concentration-time Curve From 0 to Infinity (AUCinf) of Tocilizumab
Blood samples were collected pre-dose and at the end of infusion of tocilizumab on Day 1 of Cycle 2. Additional blood samples were collected on Days 2, 3, 5, 7, 12, 14, 21 of Cycle 2, and Days 1, 7, and 21 of Cycle 3. The concentration of tocilizumab was determined in serum samples using a validated ELISA. The area under the serum concentration-time curve from 0 to infinity (AUCinf) was derived from the serum concentrations using a non-compartmental method with the software WinNonlin Enterprise version 5.2 (or above). AUCinf was computed using the linear trapezoidal rule to tlast plus Clast/Kel, where tlast is the time of the last measurable concentration, Clast is the last measurable concentration, and Kel is the apparent elimination rate, computed as the magnitude of the slope from the log-linear regression of the apparent terminal elimination phase of the serum concentration-versus-time curve.
Measured: From Day 1 of Cycle 2 to Day 21 of Cycle 3 for Group 1
Terminal Half-life (t½) of Tocilizumab
Blood samples were collected pre-dose and at the end of infusion of tocilizumab on Day 1 of Cycle 2. Additional blood samples were collected on Days 2, 3, 5, 7, 12, 14, 21 of Cycle 2, and Days 1, 7, and 21 of Cycle 3. The concentration of tocilizumab was determined in serum samples using a validated ELISA. The terminal half-life (t½) was derived from the serum concentrations using a non-compartmental method with the software WinNonlin Enterprise version 5.2 (or above).
Measured: From Day 1 of Cycle 2 to Day 21 of Cycle 3 for Group 1
Clearance (CL) of Tocilizumab
Blood samples were collected pre-dose and at the end of infusion of tocilizumab on Day 1 of Cycle 2. Additional blood samples were collected on Days 2, 3, 5, 7, 12, 14, 21 of Cycle 2, and Days 1, 7, and 21 of Cycle 3. The concentration of tocilizumab was determined in serum samples using a validated ELISA. Clearance (CL), computed as dose/AUCinf, was derived from the serum concentrations using a non-compartmental method with the software WinNonlin Enterprise version 5.2 (or above).
Measured: From Day 1 of Cycle 2 to Day 21 of Cycle 3 for Group 1
Apparent Volume of Distribution (Vz) of Tocilizumab
Blood samples were collected pre-dose and at the end of infusion of tocilizumab on Day 1 of Cycle 2. Additional blood samples were collected on Days 2, 3, 5, 7, 12, 14, 21 of Cycle 2, and Days 1, 7, and 21 of Cycle 3. The concentration of tocilizumab was determined in serum samples using a validated ELISA. The apparent volume of distribution (Vz), computed as CL/Kel where CL is clearance and Kel is the apparent elimination rate, was derived from the serum concentrations using a non-compartmental method with the software WinNonlin Enterprise version 5.2 (or above).
Measured: From Day 1 of Cycle 2 to Day 21 of Cycle 3 for Group 1
Serum Soluble Interleukin-6 Receptor (sIL-6R) Level
Blood samples were collected pre-dose and at the end of infusion of tocilizumab on Day 1 of Cycle 2. Additional blood samples were collected on Days 2, 3, 5, 7, 12, 14, and 21 of Cycle 2, and Days 1, 7, and 21 of Cycle 3. Serum levels of soluble interleukin-6 receptor were analyzed using a validated ELISA.
Measured: From Day 1 of Cycle 2 to Day 21 of Cycle 3 for Group 1
Serum C-reactive Protein (CRP) Level
Blood samples were collected pre-dose of tocilizumab infusion on Day 1 of Cycle 2 and on Days 2, 3, 5, 7, 12, 14, and 21 of Cycle 2, and on Days 1, 7, and 21 of Cycle 3. Serum levels of C-reactive protein were measured by the Tina-quant CRP (latex) high-sensitivity Roche Immunoturbidimetric method.
Measured: From Day 1 of Cycle 2 to Day 21 of Cycle 3 for Group 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jan 2010 (estimated)
- Study startDec 2009
- Primary completionFeb 2012
- Study completionFeb 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 46 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01044498
- Sponsor's protocol ID
- NP22775
- Status last verified
- Mar 2013
- First submitted
- 7 Jan 2010
- Last updated
- 1 Apr 2013
- Results posted
- Yes, on ClinicalTrials.gov
Publications
Zhang X, Rowell L, Fettner S, Lau C, Teuber D. Assessment of disease-drug-drug interaction between single-dose tocilizumab and oral contraceptives in women with active rheumatoid arthritis. Int J Clin Pharmacol Ther. 2014 Jan;52(1):27-38. doi: 10.5414/CP201951.
PubMed 24161161
Study at a glance
From the registry record, last updated by the sponsor on 1 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Multi-center, One Sequence Cross-over Drug Interaction Study to Investigate the Effect of Tocilizumab (TCZ, RO4877533) on the Pharmacokinetics and Pharmacodynamics of an Oral Contraceptive (OC) in Female Patients With Active Rheumatoid Arthritis (RA)
- ClinicalTrials.gov ID
- NCT01044498
- Acronym / sponsor ID
- NP22775
- Conditions
- Rheumatoid Arthritis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 46 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- Dec 2009
- Primary completion
- Feb 2012 (actual)
- Study completion
- Feb 2012 (actual)
- First posted
- 8 Jan 2010 (estimated)
- Results
- Posted 12 Mar 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This open-label, randomized, cross-over study evaluated the effect of tocilizumab (TCZ) on the pharmacokinetics and pharmacodynamics of a common oral contraceptive (OC) in female patients with active rheumatoid arthritis (RA) and in healthy female volunteers of child bearing age. The RA patients received OC in combination with TCZ, whereas the healthy volunteers received OC only. The RA patients received OC in 3 cycles of 21 days each; TCZ 8 mg/kg was administered once as an intravenous infusion on the first day of Cycle 2. The healthy volunteers received OC for only one 21-day cycle.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1) | Experimental | Drug: Tocilizumab, Drug: Ortho-Novum® 1/35Patients with rheumatoid arthritis received Ortho-Novum® 1/35 daily on Days 1-21 of 3 consecutive 28-day cycles. On the first day of Cycle 2, patients received tocilizumab 8 mg/kg administered intravenously. |
| Ortho-Novum® 1/35 (Group 2) | Other | Drug: Ortho-Novum® 1/35Healthy volunteers received Ortho-Novum® 1/35 tablets daily on Days 1-21 of one 28-day cycle. |
Who may qualify
- Ages
- 18 to 44 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Adult patients with child bearing potential, 18-44 years of age.
- Rheumatoid arthritis (RA) for over 6 months duration.
- On oral contraceptive without interruption for at least 3 months with normal cycle control.
- Treatment with disease-modifying anth-rheumatic drugs (DMARD) for at least 12 weeks prior to study start.
- Body weight < 150 kg.
Key exclusion criteria (4 listed)
- Functional class IV rheumatoid arthritis (American College of Rheumatology [ACR] classification).
- History of amenorrhea (unrelated to pregnancy).
- History or current inflammatory joint disease other than RA.
- Rheumatic autoimmune disease other than RA.
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 |
|---|---|---|
| TocilizumabAlso: RoActemra, ActemraTocilizumab 8 mg/kg was administered in a single 1-hour infusion on Day 1 of Cycle 2. | Drug | Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1) |
| Ortho-Novum® 1/35Each Ortho-Novum® 1/35 tablet contained 1 mg of norethindrone and 0.035 mg of ethinyl estradiol. | Drug | Ortho-Novum® 1/35 (Group 2), Tocilizumab 8 mg/kg + Ortho-Novum® 1/35 (Group 1) |
Primary outcome
Serum Progesterone Level
Time frame: Day 21 of Cycles 1-3 for Group 1 and Day 21 of Cycle 1 for Group 2
Blood samples were collected prior to the administration of Ortho-Novum® 1/35 on Day 21 of each cycle. Serum levels of progesterone were quantitatively determined using the ADVIA Centaur and ADVIA Centaur XP systems (Siemens Healthcare Diagnostics Inc., Tarrytown, NY, USA). The assay was a competitive immunoassay using direct chemiluminescent technology.
13 secondary outcomes
Maximum Observed Plasma Concentration (Cmax) of Ethinyl Estradiol and Norethindrone
Time frame: Day 7 of Cycles 1-3 for Group 1 and Day 7 of Cycle 1 for Group 2
Time to Reach the Maximum Plasma Concentration (Tmax) of Ethinyl Estradiol and Norethindrone
Time frame: Day 7 of Cycles 1-3 for Group 1 and Day 7 of Cycle 1 for Group 2
Area Under the Plasma Concentration-time Curve From 0 to 24 Hours (AUC0-24) of Ethinyl Estradiol and Norethindrone
Time frame: Day 7 of Cycles 1-3 for Group 1 and Day 7 of Cycle 1 for Group 2
Terminal Half-life (t½) of Ethinyl Estradiol and Norethindrone
Time frame: Day 7 of Cycles 1-3 for Group 1 and Day 7 of Cycle 1 for Group 2
Apparent Oral Clearance (CL/F) of Ethinyl Estradiol and Norethindrone
Time frame: Day 7 of Cycles 1-3 for Group 1 and Day 7 of Cycle 1 for Group 2
Maximum Observed Serum Concentration (Cmax) of Tocilizumab
Time frame: From Day 1 of Cycle 2 to Day 21 of Cycle 3 for Group 1
Time to Reach Maximum Serum Concentration (Tmax) of Tocilizumab
Time frame: From Day 1 of Cycle 2 to Day 21 of Cycle 3 for Group 1
Area Under the Serum Concentration-time Curve From 0 to Infinity (AUCinf) of Tocilizumab
Time frame: From Day 1 of Cycle 2 to Day 21 of Cycle 3 for Group 1
Terminal Half-life (t½) of Tocilizumab
Time frame: From Day 1 of Cycle 2 to Day 21 of Cycle 3 for Group 1
Clearance (CL) of Tocilizumab
Time frame: From Day 1 of Cycle 2 to Day 21 of Cycle 3 for Group 1
Apparent Volume of Distribution (Vz) of Tocilizumab
Time frame: From Day 1 of Cycle 2 to Day 21 of Cycle 3 for Group 1
Serum Soluble Interleukin-6 Receptor (sIL-6R) Level
Time frame: From Day 1 of Cycle 2 to Day 21 of Cycle 3 for Group 1
Serum C-reactive Protein (CRP) Level
Time frame: From Day 1 of Cycle 2 to Day 21 of Cycle 3 for Group 1
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Apr 2013.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 24161161Zhang X, Rowell L, Fettner S, Lau C, Teuber D. Assessment of disease-drug-drug interaction between single-dose tocilizumab and oral contraceptives in women with active rheumatoid arthritis. Int J Clin Pharmacol Ther. 2014 Jan;52(1):27-38. doi: 10.5414/CP201951.
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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.
Clinical Trials study director
Hoffmann-La Roche
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Tocilizumab and Ortho-Novum® 1/35 in people with Rheumatoid Arthritis, run by Hoffmann-La Roche at 6 sites 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 5 inclusion and 4 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 Apr 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 12 Mar 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Serum Progesterone Level (time frame: Day 21 of Cycles 1-3 for Group 1 and Day 21 of Cycle 1 for Group 2). 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 NCT01044498, which also lists 1 linked publication.
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 Apr 2013.