A Phase 1 interventional study of Cladribine and Placebo in Relapsing Multiple Sclerosis (RMS), sponsored by Merck KGaA, Darmstadt, Germany. Completed at 7 sites in 2 countries. Open to female participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2024-03-15.
Sponsored by Merck KGaA, Darmstadt, Germany · Phase 1, Interventional, and Other
The purpose of this study was to investigate the potential effects of cladribine on the pharmacokinetics (PK) of monophasic oral contraceptive microgynon® by assessment of its constituents, ethinyl estradiol (EE) and levonorgestrel (LNG).
3,264 studies on the registry are indexed under Multiple Sclerosis; 659 are open to participants now.
This study's enrollment of 28 is below the median of 50 across 2,201 interventional studies indexed under Multiple Sclerosis.
Browse Multiple Sclerosis studies →Merck KGaA, Darmstadt, Germany is the lead sponsor of 275 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Period 1: Participants received a single once daily dose of Microgynon® tablet from Day 1-8 followed by 5-day once-daily Cladribine 10 to 20 milligram(mg) depending on body weight along with Microgynon® tablet once daily from Day 9-28. Period 2: Participants received a single once daily dose of Microgynon® tablet from Day 1-8 followed by 5-day once-daily Cladribine matched Placebo along with Microgynon® from Day 9-14. From Day 15-28 participants received once daily Microgynon® along with 5-day once-daily Cladribine 10 to 20 mg depending on body weight.
Drug: Cladribine · Drug: Placebo · Drug: Microgynon®
Participants 5-day once daily Period 1: Participants received a single once daily dose of Microgynon® tablet from Day 1-8 followed by 5-day once-daily Cladribine matched Placebo along with Microgynon® tablet once daily from Day 9-28. Period 2: Participants received a single once daily dose of Microgynon® tablet from Day 1-8 followed by 5-day once-daily Cladribine 10 to 20 mg depending on body weight along with Microgynon® tablet once daily from Day 9-28.
Drug: Cladribine · Drug: Placebo · Drug: Microgynon®
Participants received Microgynon® for 21 days, starting on the first day of the menstrual cycle.
Drug: Microgynon®
Participants received cladribine once-daily for 5 consecutive days in treatment period 1 and 2.
Participants received placebo matched to cladribine once-daily for 5 consecutive days in treatment period 1 and 2.
Participants received Microgynon® tablet once daily for 21 days in treatment period 1 and 2. Participants received Microgynon® for 21 days, starting on the first day of the menstrual cycle in Run-in period.
Area Under the Plasma Concentration-Time Curve From Zero to Tau at Steady State (AUCt,ss) of Ethinyl Estradiol and Levonorgestrel
Area under the plasma concentration-time curve from zero to tau at steady state (AUCt,ss) of ethinyl estradiol and levonorgestrel were reported. Calculated using descriptive statistics.
Time frame: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 14
Maximum Observed Plasma Concentration in Steady State (Cmax,ss) of Ethinyl Estradiol And Levonorgestrel
Maximum observed plasma concentration in steady state (Cmax,ss) of ethinyl estradiol and levonorgestrel were reported. Calculated using descriptive statistics.
Time frame: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 14
Minimum Observed Plasma Concentration in Steady State (Cmin,ss) of Ethinyl Estradiol and Levonorgestrel
Minimum observed plasma concentration in steady state (Cmin,ss) of ethinyl estradiol and levonorgestrel were reported. Calculated from descriptive statistics.
Time frame: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 14
Plasma Concentration at End of Dosing Interval at Steady State (Ctrough) of Ethinyl Estradiol and Levonorgestrel
Plasma concentration at end of dosing interval at steady state (Ctrough) of ethinyl estradiol and levonorgestrel were reported. Calculated from descriptive statistics.
Time frame: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 14
Time to Reach the Maximum Observed Plasma Concentration At Steady State (Tmax,ss) of Ethinyl Estradiol and Levonorgestrel
Time to reach the maximum observed plasma concentration at steady state (Tmax,ss) of Ethinyl Estradiol and Levonorgestrel were reported. Calculated using descriptive statistics.
Time frame: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 14
Average Plasma Concentration at Steady State (Cav,ss) of Ethinyl Estradiol and Levonorgestrel
Average plasma concentration at steady state (Cav,ss) ) of Ethinyl Estradiol and Levonorgestrel were reported. Cav,ss =AUCt,ss/ tau, where, AUCt,ss was defined as the area under the plasma concentration-time curve in steady state during a complete dosing interval (tau) and Tau is the Complete dosing interval. Calculated using descriptive statistics.
Time frame: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 14
Peak-to-Trough Fluctuation Over One Complete Dosing Interval At Steady State (PTF%)
The PTF within complete dosing interval at steady state, calculated as PTF (%) = (\[Cmax - Cmin\]/Cav) multiplied by 100. Here, Cmin means the minimum plasma concentration, Cmax means the maximum plasma concentration and Cav means the average plasma concentration of drug and metabolite.
Time frame: Pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 14
Number of Participants With Treatment -Emergent Adverse Events (TEAEs)
Adverse event (AE): any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. Serious AE: an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAE: AE with onset after start of treatment or with onset date before the treatment start date but worsening after the treatment start date. TEAEs included both serious and non-serious TEAEs.
Time frame: Up to Day 84
Number of Participants With Clinically Relevant Change From Baseline in Laboratory Values
Laboratory investigation included hematology, biochemistry and urinalysis. Clinical relevance was decided by the investigator. Number of participants with clinically relevant change from baseline in laboratory values were reported.
Time frame: Up to Day 84
Number of Participants With Clinically Relevant Change From Baseline in Electrocardiogram (ECG)
The 12-lead ECGs were recorded after the participants have rested for at least 5 minutes in supine position. The parameters included heart rate (HR), Respiratory Rate, Pulse Rate, QRS, QT and QTcB calculated by the Bazett formula. Clinical Relevance was decided by the investigator. Number of participants with clinical relevant change from baseline in ECG parameters were reported.
Time frame: Up to Day 84
Number of Participants With Clinically Relevant Change From Baseline in Vital Signs
Vital signs included oral body temperature, systolic blood pressure, diastolic blood pressure, and pulse rate. Clinical Relevance was decided by the investigator. Number of participants with clinically relevant change from baseline in vital signs were reported.
Time frame: Up to Day 84
Maximum Plasma Concentration (Cmax) of Cladribine
Cmax was obtained from plasma concentration time curve.
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5 and 2 hours post-dose on Day 10, 11, 12 and 13
Time to Reach the Maximum Observed Plasma Concentration (Tmax) of Cladribine
Tmax was obtained from plasma concentration time curve.
Time frame: Pre-dose, 0.25, 0.5, 1, 1.5 and 2 hours post-dose on Day 10, 11, 12 and 13
| Milestone | Microgynon® | Sequence 1: First Cladribine, Then Placebo | Sequence 2: First Placebo, Then Cladribine |
|---|---|---|---|
| Started | 28 | 0 | 0 |
| Safety analysis set | 28 | 0 | 0 |
| Pharmacokinetic analysis set | 21 | 0 | 0 |
| Completed | 24 | 0 | 0 |
| Not completed | 4 | 0 | 0 |
| Withdrew: Other | 4 | 0 | 0 |
| Milestone | Microgynon® | Sequence 1: First Cladribine, Then Placebo | Sequence 2: First Placebo, Then Cladribine |
|---|---|---|---|
| Started | 0 | 13 | 11 |
| Completed | 0 | 13 | 10 |
| Not completed | 0 | 0 | 1 |
| Withdrew: Other | 0 | 0 | 1 |
| Milestone | Microgynon® | Sequence 1: First Cladribine, Then Placebo | Sequence 2: First Placebo, Then Cladribine |
|---|---|---|---|
| Started | 0 | 13 | 10 |
| Completed | 0 | 13 | 10 |
| Not completed | 0 | 0 | 0 |
Area under the plasma concentration-time curve from zero to tau at steady state (AUCt,ss) of ethinyl estradiol and levonorgestrel were reported. Calculated using descriptive statistics.
| hour*picograms per millilitre(h*pg/ml) | Microgynon + Cladribine | Microgynon + Placebo |
|---|---|---|
| Ethinyl Estradiol | 789 ± 56.9 | 817 ± 52.6 |
| Levonorgestrel | 91400 ± 45.2 | 92000 ± 46.8 |
Maximum observed plasma concentration in steady state (Cmax,ss) of ethinyl estradiol and levonorgestrel were reported. Calculated using descriptive statistics.
| pg/ml | Microgynon + Cladribine | Microgynon + Placebo |
|---|---|---|
| Ethinyl Estradiol | 88.3 ± 46.5 | 88.1 ± 45.7 |
| Levonorgestrel | 7950 ± 33.9 | 8150 ± 34.6 |
Minimum observed plasma concentration in steady state (Cmin,ss) of ethinyl estradiol and levonorgestrel were reported. Calculated from descriptive statistics.
| pg/ml | Microgynon + Cladribine | Microgynon + Placebo |
|---|---|---|
| Ethinyl Estradiol | 14.8 ± 66.3 | 14.7 ± 65.6 |
| Levonorgestrel | 2520 ± 49.5 | 2430 ± 56.3 |
Plasma concentration at end of dosing interval at steady state (Ctrough) of ethinyl estradiol and levonorgestrel were reported. Calculated from descriptive statistics.
| pg/ml | Microgynon + Cladribine | Microgynon + Placebo |
|---|---|---|
| Ethinyl Estradiol | 15.5 ± 66.8 | 15.4 ± 66.9 |
| Levonorgestrel | 2580 ± 48.5 | 2580 ± 56.0 |
Time to reach the maximum observed plasma concentration at steady state (Tmax,ss) of Ethinyl Estradiol and Levonorgestrel were reported. Calculated using descriptive statistics.
| hours | Microgynon + Cladribine | Microgynon + Placebo |
|---|---|---|
| Ethinyl Estradiol | 1.00 (0 to 2.00) | 1.00 (0.417 to 2.00) |
| Levonorgestrel | 1.00 (0.417 to 2.00) | 1.00 (0.417 to 2.00) |
Average plasma concentration at steady state (Cav,ss) ) of Ethinyl Estradiol and Levonorgestrel were reported. Cav,ss =AUCt,ss/ tau, where, AUCt,ss was defined as the area under the plasma concentration-time curve in steady state during a complete dosing interval (tau) and Tau is the Complete dosing interval. Calculated using descriptive statistics.
| pg/ml | Microgynon + Cladribine | Microgynon + Placebo |
|---|---|---|
| Ethinyl Estradiol | 32.9 ± 56.9 | 34.1 ± 52.6 |
| Levonorgestrel | 3810 ± 45.2 | 3830 ± 46.8 |
The PTF within complete dosing interval at steady state, calculated as PTF (%) = (\[Cmax - Cmin\]/Cav) multiplied by 100. Here, Cmin means the minimum plasma concentration, Cmax means the maximum plasma concentration and Cav means the average plasma concentration of drug and metabolite.
| percentage fluctuation | Microgynon + Cladribine | Microgynon + Placebo |
|---|---|---|
| Ethinyl Estradiol | 220 ± 28.0 | 213 ± 23.2 |
| Levonorgestrel | 140 ± 29.7 | 145 ± 29.0 |
Adverse event (AE): any unfavourable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. Serious AE: an AE that resulted in any of the following outcomes: death; life threatening; persistent/significant disability/incapacity; initial or prolonged inpatient hospitalization; congenital anomaly/birth defect or was otherwise considered medically important. TEAE: AE with onset after start of treatment or with onset date before the treatment start date but worsening after the treatment start date. TEAEs included both serious and non-serious TEAEs.
| Participants | Run-in Period: Microgynon (Day -28 to -1) | Sequence 1 Period 1: Microgynon Alone (Day 1-8) | Sequence 1 Period 1: Microgynon + Cladribine (Day 9-28) | Sequence 1 Period 2: Microgynon Alone (Day 1-8) | Sequence 1 Period 2: Microgynon + Placebo (Day 9-14) | Sequence 1 Period 2: Microgynon + Cladribine (Day 15-28) | Sequence 2 Period 1: Microgynon Alone (Day 1-8) | Sequence 2 Period 1: Microgynon + Placebo (Day 9-28) | Sequence 2 Period 2: Microgynon Alone (Day 1-8) | Sequence 2 Period 2: Microgynon + Cladribine (Day 9-28) |
|---|---|---|---|---|---|---|---|---|---|---|
| Number of Participants With Treatment -Emergent Adverse Events (TEAEs) | 7 | 3 | 9 | 5 | 5 | 4 | 1 | 5 | 1 | 7 |
Laboratory investigation included hematology, biochemistry and urinalysis. Clinical relevance was decided by the investigator. Number of participants with clinically relevant change from baseline in laboratory values were reported.
| Participants | Run-in Period: Microgynon (Day -28 to -1) | Sequence 1 Period 1: Microgynon Alone (Day 1-8) | Sequence 1 Period 1: Microgynon + Cladribine (Day 9-28) | Sequence 1 Period 2: Microgynon Alone (Day 1-8) | Sequence 1 Period 2: Microgynon + Placebo (Day 9-14) | Sequence 1 Period 2: Microgynon + Cladribine (Day 15-28) | Sequence 2 Period 1: Microgynon Alone (Day 1-8) | Sequence 2 Period 1: Microgynon + Placebo (Day 9-28) | Sequence 2 Period 2: Microgynon Alone (Day 1-8) | Sequence 2 Period 2: Microgynon + Cladribine (Day 9-28) |
|---|---|---|---|---|---|---|---|---|---|---|
| Number of Participants With Clinically Relevant Change From Baseline in Laboratory Values | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
The 12-lead ECGs were recorded after the participants have rested for at least 5 minutes in supine position. The parameters included heart rate (HR), Respiratory Rate, Pulse Rate, QRS, QT and QTcB calculated by the Bazett formula. Clinical Relevance was decided by the investigator. Number of participants with clinical relevant change from baseline in ECG parameters were reported.
| Participants | Run-in Period: Microgynon (Day -28 to -1) | Sequence 1 Period 1: Microgynon Alone (Day 1-8) | Sequence 1 Period 1: Microgynon + Cladribine (Day 9-28) | Sequence 1 Period 2: Microgynon Alone (Day 1-8) | Sequence 1 Period 2: Microgynon + Placebo (Day 9-14) | Sequence 1 Period 2: Microgynon + Cladribine (Day 15-28) | Sequence 2 Period 1: Microgynon Alone (Day 1-8) | Sequence 2 Period 1: Microgynon + Placebo (Day 9-28) | Sequence 2 Period 2: Microgynon Alone (Day 1-8) | Sequence 2 Period 2: Microgynon + Cladribine (Day 9-28) |
|---|---|---|---|---|---|---|---|---|---|---|
| Number of Participants With Clinically Relevant Change From Baseline in Electrocardiogram (ECG) | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Vital signs included oral body temperature, systolic blood pressure, diastolic blood pressure, and pulse rate. Clinical Relevance was decided by the investigator. Number of participants with clinically relevant change from baseline in vital signs were reported.
| Participants | Run-in Period: Microgynon (Day -28 to -1) | Sequence 1 Period 1: Microgynon Alone (Day 1-8) | Sequence 1 Period 1: Microgynon + Cladribine (Day 9-28) | Sequence 1 Period 2: Microgynon Alone (Day 1-8) | Sequence 1 Period 2: Microgynon + Placebo (Day 9-14) | Sequence 1 Period 2: Microgynon + Cladribine (Day 15-28) | Sequence 2 Period 1: Microgynon Alone (Day 1-8) | Sequence 2 Period 1: Microgynon + Placebo (Day 9-28) | Sequence 2 Period 2: Microgynon Alone (Day 1-8) | Sequence 2 Period 2: Microgynon + Cladribine (Day 9-28) |
|---|---|---|---|---|---|---|---|---|---|---|
| Number of Participants With Clinically Relevant Change From Baseline in Vital Signs | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 | 0 |
Cmax was obtained from plasma concentration time curve.
| nanogram per milliliter (ng/mL) | Microgynon + Cladribine |
|---|---|
| Day 10 | 29.3 ± 39.4 |
| Day 11 | 28.2 ± 45.5 |
| Day 12 | 23.6 ± 37.5 |
| Day 13 | 22.7 ± 40.7 |
Tmax was obtained from plasma concentration time curve.
| hours | Microgynon + Cladribine |
|---|---|
| Day 10 | 0.500 (0.500 to 1.50) |
| Day 11 | 0.500 (0.250 to 1.50) |
| Day 12 | 0.500 (0.500 to 1.50) |
| Day 13 | 0.500 (0.250 to 2.00) |
Collected over Up to Day 84. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Run-in Period: Microgynon (Day -28 to -1) | 0/28 (0%) | 0/28 (0%) | 7/28 (25%) |
| Sequence 1 Period 1: Microgynon Alone (Day 1-8) | 0/13 (0%) | 0/13 (0%) | 3/13 (23.1%) |
| Sequence 1 Period 1: Microgynon + Cladribine (Day 9-28) | 0/13 (0%) | 0/13 (0%) | 9/13 (69.2%) |
| Sequence 1 Period 2: Microgynon Alone (Day 1-8) | 0/13 (0%) | 0/13 (0%) | 5/13 (38.5%) |
| Sequence 1 Period 2: Microgynon + Placebo (Day 9-14) | 0/13 (0%) | 0/13 (0%) | 5/13 (38.5%) |
| Sequence 1 Period 2: Microgynon + Cladribine (Day 15-28) | 0/13 (0%) | 0/13 (0%) | 4/13 (30.8%) |
| Sequence 2 Period 1: Microgynon Alone (Day 1-8) | 0/11 (0%) | 0/11 (0%) | 1/11 (9.1%) |
| Sequence 2 Period 1: Microgynon + Placebo (Day 9-28) | 0/10 (0%) | 0/10 (0%) | 5/10 (50%) |
| Sequence 2 Period 2: Microgynon Alone (Day 1-8) | 0/10 (0%) | 0/10 (0%) | 1/10 (10%) |
| Sequence 2 Period 2: Microgynon + Cladribine (Day 9-28) | 0/10 (0%) | 0/10 (0%) | 7/10 (70%) |
| Event | Run-in Period: Microgynon (Day -28 to -1) | Sequence 1 Period 1: Microgynon Alone (Day 1-8) | Sequence 1 Period 1: Microgynon + Cladribine (Day 9-28) | Sequence 1 Period 2: Microgynon Alone (Day 1-8) | Sequence 1 Period 2: Microgynon + Placebo (Day 9-14) | Sequence 1 Period 2: Microgynon + Cladribine (Day 15-28) | Sequence 2 Period 1: Microgynon Alone (Day 1-8) | Sequence 2 Period 1: Microgynon + Placebo (Day 9-28) | Sequence 2 Period 2: Microgynon Alone (Day 1-8) | Sequence 2 Period 2: Microgynon + Cladribine (Day 9-28) |
|---|---|---|---|---|---|---|---|---|---|---|
| HeadacheNervous system disorders | 3/28 | 1/13 | 6/13 | 3/13 | 2/13 | 3/13 | 1/11 | 3/10 | 0/10 | 3/10 |
| FatigueGeneral disorders | 1/28 | 0/13 | 1/13 | 0/13 | 2/13 | 1/13 | 0/11 | 2/10 | 0/10 | 3/10 |
| NauseaGastrointestinal disorders | 0/28 | 0/13 | 0/13 | 0/13 | 0/13 | 0/13 | 0/11 | 0/10 | 0/10 | 2/10 |
| MigraineNervous system disorders | 1/28 | 0/13 | 0/13 | 0/13 | 0/13 | 0/13 | 0/11 | 0/10 | 0/10 | 1/10 |
| Sinus BradycardiaCardiac disorders | 0/28 | 1/13 | 0/13 | 0/13 | 0/13 | 0/13 | 0/11 | 1/10 | 0/10 | 0/10 |
| Feeling ColdGeneral disorders | 0/28 | 0/13 | 0/13 | 0/13 | 0/13 | 0/13 | 0/11 | 1/10 | 0/10 | 0/10 |
| Mucosal DrynessGeneral disorders | 0/28 | 0/13 | 0/13 | 0/13 | 0/13 | 0/13 | 0/11 | 1/10 | 0/10 | 0/10 |
| NasopharyngitisInfections and infestations | 0/28 | 1/13 | 0/13 | 1/13 | 0/13 | 0/13 | 0/11 | 1/10 | 0/10 | 0/10 |
| Decreased AppetiteMetabolism and nutrition disorders | 0/28 | 0/13 | 1/13 | 0/13 | 1/13 | 0/13 | 0/11 | 1/10 | 0/10 | 0/10 |
| Multiple Sclerosis RelapseNervous system disorders | 0/28 | 0/13 | 0/13 | 0/13 | 0/13 | 0/13 | 0/11 | 1/10 | 0/10 | 1/10 |
Safety Analysis Set included all participants who were administered any dose of the trial medication.
| Age, Continuous(Years) | All Participants |
|---|---|
| Mean | 34 ± 6.3 |
| Sex: Female, Male(Participants) | All Participants |
|---|---|
| Female | 28 |
| Male | 0 |
| Ethnicity (NIH/OMB)(Participants) | All Participants |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 28 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | All Participants |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 28 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No — We are committed to enhancing public health through responsible sharing of clinical trial data. Following approval of a new product or a new indication for an approved product in both the US and the European Union, the study sponsor and/or its affiliated companies will share study protocols, anonymized patient data and study level data, and redacted clinical study reports with qualified scientific and medical researchers, upon request, as necessary for conducting legitimate research. Further information on how to request data can be found on our website bit.ly/IPD21
Ran from Jan 2019 to primary completion in Sep 2022, 43 months.
Results were first posted in Mar 2024, 1 year 6 months after primary completion.
Of 38 industry-sponsored phase 1 interventional studies under Multiple Sclerosis, half reached primary completion within 13 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 32. This study's 43 months is above that.
Counting every sponsor, half of 91 studies reached it within 30 months; a quarter within 9 and three quarters within 56.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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Merck KGaA, Darmstadt, Germany →