| ID | Type | Description | Link |
|---|---|---|---|
| 2018-001015-70 | EudraCT Number |
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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sequence 1: First Cladribine, Then Placebo | Experimental | 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. |
|
| Sequence 2: First Placebo, Then Cladribine | Experimental | 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. |
|
| Microgynon® | Experimental | Participants received Microgynon® for 21 days, starting on the first day of the menstrual cycle. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cladribine | Drug | Participants received cladribine once-daily for 5 consecutive days in treatment period 1 and 2. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 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. | 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. | 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. | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Medical Responsible | Merck KGaA, Darmstadt, Germany | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| St. Josef und St. Elisabeth Hospital gGmbH | Bochum | Germany | ||||
| Nuvisan GmbH |
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| Label | URL |
|---|---|
| Trial Awareness and Transparency website | View source |
| Medical Information Location Map - Med Info Contacts | View source |
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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
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A total of 37 participants were screened, out of which 28 participants enrolled in the study.
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| ID | Title | Description |
|---|---|---|
| FG000 | Microgynon® | Participants received Microgynon® for 21 days, starting on the first day of the menstrual cycle. |
| FG001 | Sequence 1: First Cladribine, Then Placebo | 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. |
| FG002 | Sequence 2: First Placebo, Then Cladribine | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Run-in-Period (Day 0 to Day 28) |
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| Period 1 |
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| Period 2 |
|
Safety Analysis Set included all participants who were administered any dose of the trial medication.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Participants | All participants who received Microgynon® for 21 days and received cladribine treatment of 10 to 20 mg depending on body weight or matching placebo treatment in either of Treatment groups. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Pharmacokinetic Analysis Set included all participants in the Safety Set without clinically important protocol deviations/violations and absence of factors/events likely to affect Pharmacokinetics (PK). | Posted | Geometric Mean | Geometric Coefficient of Variation | hour*picograms per millilitre(h*pg/ml) | Pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 14 |
|
Up to Day 84
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Run-in Period: Microgynon (Day -28 to -1) | Participants received Microgynon for 21 days, starting on the first day of the menstrual cycle. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Leukocytosis | Blood and lymphatic system disorders | MedDRA® Version 24.1 | Non-systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Communication Center | Merck Healthcare KGaA, Darmstadt, Germany, an affiliate of Merck KGaA, Darmstadt, Germany | +49 6151-72-5200 | service@emdgroup.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Jul 29, 2021 | Aug 25, 2023 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Oct 12, 2020 | Aug 25, 2023 | SAP_001.pdf |
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| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| ID | Term |
|---|---|
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
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| ID | Term |
|---|---|
| D017338 | Cladribine |
| C072593 | ethinyl estradiol, levonorgestrel drug combination |
| ID | Term |
|---|---|
| D015762 | 2-Chloroadenosine |
| D000241 | Adenosine |
| D011684 | Purine Nucleosides |
| D011687 | Purines |
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| Placebo | Drug | Participants received placebo matched to cladribine once-daily for 5 consecutive days in treatment period 1 and 2. |
|
| Microgynon® | Drug | 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. |
|
| 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. | 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. | Pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 14 |
| 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. | 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. | 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. | Up to Day 84 |
| Maximum Plasma Concentration (Cmax) of Cladribine | Cmax was obtained from plasma concentration time curve. | 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. | Pre-dose, 0.25, 0.5, 1, 1.5 and 2 hours post-dose on Day 10, 11, 12 and 13 |
| Neu-Ulm |
| Germany |
| M.A. - LEK A.M.Maciejowscy SC. | Katowice | Poland |
| BioResearch Group Sp. z o. o | Nadarzyn | Poland |
| IKARDIA Hospital Cardiology | Nałęczów | Poland |
| BioVirtus Research Site Sp | Otwock | Poland |
| MTZ Clinical Research Sp. z o.o. | Warsaw | Poland |
| NOT COMPLETED |
|
|
| NOT COMPLETED |
|
| Years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | Microgynon + Placebo | Participants received 5-day once daily cladribine matched placebo from Day 15 to Day 19 in Period 1 and from Day 15 to Day 19 in Period 2 along with Microgynon® tablet (ethinyl estradiol 30 mcg, levonorgestrel 150 mcg) once daily from Day 1 to Day 21 in either treatment period 1 or period 2. |
|
|
| Primary | 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. | Pharmacokinetic Analysis Set included all participants in the Safety Set without clinically important protocol deviations/violations and absence of factors/events likely to affect Pharmacokinetics (PK). | Posted | Geometric Mean | Geometric Coefficient of Variation | pg/ml | Pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 14 |
|
|
|
| Primary | 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. | Pharmacokinetic Analysis Set included all participants in the Safety Set without clinically important protocol deviations/violations and absence of factors/events likely to affect Pharmacokinetics (PK). | Posted | Geometric Mean | Geometric Coefficient of Variation | pg/ml | Pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 14 |
|
|
|
| Primary | 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. | Pharmacokinetic Analysis Set included all participants in the Safety Set without clinically important protocol deviations/violations and absence of factors/events likely to affect Pharmacokinetics (PK). | Posted | Geometric Mean | Geometric Coefficient of Variation | pg/ml | Pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 14 |
|
|
|
| Primary | 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. | Pharmacokinetic Analysis Set included all participants in the Safety Set without clinically important protocol deviations/violations and absence of factors/events likely to affect Pharmacokinetics (PK). | Posted | Median | Full Range | hours | Pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 14 |
|
|
|
| Primary | 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. | Pharmacokinetic Analysis Set included all participants in the Safety Set without clinically important protocol deviations/violations and absence of factors/events likely to affect Pharmacokinetics (PK). | Posted | Geometric Mean | Geometric Coefficient of Variation | pg/ml | Pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 14 |
|
|
|
| Primary | 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. | Pharmacokinetic Analysis Set included all participants in the Safety Set without clinically important protocol deviations/violations and absence of factors/events likely to affect Pharmacokinetics (PK). | Posted | Geometric Mean | Geometric Coefficient of Variation | percentage fluctuation | Pre-dose, 0.5, 1, 2, 4, 6, 8, 12 and 24 hours post-dose on Day 14 |
|
|
|
| Secondary | 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. | Safety Analysis Set included all participant who were administered any dose of the trial medication. | Posted | Count of Participants | Participants | Up to Day 84 |
|
|
|
| Secondary | 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. | Safety Analysis Set included all participant who were administered any dose of the trial medication. | Posted | Count of Participants | Participants | Up to Day 84 |
|
|
|
| Secondary | 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. | Safety Analysis Set included all participant who were administered any dose of the trial medication. | Posted | Count of Participants | Participants | Up to Day 84 |
|
|
|
| Secondary | 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. | Safety Analysis Set included all participant who were administered any dose of the trial medication. | Posted | Count of Participants | Participants | Up to Day 84 |
|
|
|
| Secondary | Maximum Plasma Concentration (Cmax) of Cladribine | Cmax was obtained from plasma concentration time curve. | Pharmacokinetic Analysis Set included all participants in the Safety Set without clinically important protocol deviations/violations and absence of factors/events likely to affect Pharmacokinetics (PK). | Posted | Geometric Mean | Geometric Coefficient of Variation | nanogram per milliliter (ng/mL) | Pre-dose, 0.25, 0.5, 1, 1.5 and 2 hours post-dose on Day 10, 11, 12 and 13 |
|
|
|
| Secondary | Time to Reach the Maximum Observed Plasma Concentration (Tmax) of Cladribine | Tmax was obtained from plasma concentration time curve. | Pharmacokinetic Analysis Set included all participants in the Safety Set without clinically important protocol deviations/violations and absence of factors/events likely to affect Pharmacokinetics (PK). | Posted | Median | Full Range | hours | Pre-dose, 0.25, 0.5, 1, 1.5 and 2 hours post-dose on Day 10, 11, 12 and 13 |
|
|
|
| 0 |
| 28 |
| 0 |
| 28 |
| 7 |
| 28 |
| EG001 | Sequence 1 Period 1: Microgynon Alone (Day 1-8) | Participants received a single once daily dose of Microgynon® tablet from Day 1-8. | 0 | 13 | 0 | 13 | 3 | 13 |
| EG002 | Sequence 1 Period 1: Microgynon + Cladribine (Day 9-28) | Participants received 5-day once daily dose of Cladribine 10 to 20 milligram(mg) depending on body weight along with Microgynon® tablet once daily from Day 9-28. | 0 | 13 | 0 | 13 | 9 | 13 |
| EG003 | Sequence 1 Period 2: Microgynon Alone (Day 1-8) | Participants received a single once daily dose of Microgynon® tablet from Day 1-8. | 0 | 13 | 0 | 13 | 5 | 13 |
| EG004 | Sequence 1 Period 2: Microgynon + Placebo (Day 9-14) | Participants received 5-day once daily dose of Cladribine matched Placebo along with Microgynon® from Day 9-14. | 0 | 13 | 0 | 13 | 5 | 13 |
| EG005 | Sequence 1 Period 2: Microgynon + Cladribine (Day 15-28) | Participants received 5-day once-daily dose of Cladribine 10 to 20 mg depending on body weight along with Microgynon® tablet once daily from Day 15-28. | 0 | 13 | 0 | 13 | 4 | 13 |
| EG006 | Sequence 2 Period 1: Microgynon Alone (Day 1-8) | Participants received a single once daily dose of Microgynon® tablet from Day 1-8. | 0 | 11 | 0 | 11 | 1 | 11 |
| EG007 | Sequence 2 Period 1: Microgynon + Placebo (Day 9-28) | Participants received 5-day once-daily dose of Cladribine matched Placebo along with Microgynon® from Day 9-28. | 0 | 10 | 0 | 10 | 5 | 10 |
| EG008 | Sequence 2 Period 2: Microgynon Alone (Day 1-8) | Participants received a single once daily dose of Microgynon® tablet from Day 1-8. | 0 | 10 | 0 | 10 | 1 | 10 |
| EG009 | Sequence 2 Period 2: Microgynon + Cladribine (Day 9-28) | Participants received 5-day once-daily dose of Cladribine 10 to 20 mg depending on body weight along with Microgynon® tablet once daily from Day 9-28. | 0 | 10 | 0 | 10 | 7 | 10 |
| Lymphocytosis | Blood and lymphatic system disorders | MedDRA® Version 24.1 | Non-systematic Assessment |
|
| Fatigue | General disorders | MedDRA® Version 24.1 | Non-systematic Assessment |
|
| Tonsilitis | Infections and infestations | MedDRA® Version 24.1 | Non-systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | MedDRA® Version 24.1 | Non-systematic Assessment |
|
| Haematocrit Decreased | Investigations | MedDRA® Version 24.1 | Non-systematic Assessment |
|
| Headache | Nervous system disorders | MedDRA® Version 24.1 | Non-systematic Assessment |
|
| Migraine | Nervous system disorders | MedDRA® Version 24.1 | Non-systematic Assessment |
|
| Hypomenorrhoea | Reproductive system and breast disorders | MedDRA® Version 24.1 | Non-systematic Assessment |
|
| Intermenstrual Bleeding | Reproductive system and breast disorders | MedDRA® Version 24.1 | Non-systematic Assessment |
|
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA® Version 24.1 | Non-systematic Assessment |
|
| Sinus Bradycardia | Cardiac disorders | MedDRA® Version 24.1 | Non-systematic Assessment |
|
| Chills | General disorders | MedDRA® Version 24.1 | Non-systematic Assessment |
|
| Feeling Cold | General disorders | MedDRA® Version 24.1 | Non-systematic Assessment |
|
| Mucosal Dryness | General disorders | MedDRA® Version 24.1 | Non-systematic Assessment |
|
| Pain | General disorders | MedDRA® Version 24.1 | Non-systematic Assessment |
|
| Nasopharyngitis | Infections and infestations | MedDRA® Version 24.1 | Non-systematic Assessment |
|
| Decreased Appetite | Metabolism and nutrition disorders | MedDRA® Version 24.1 | Non-systematic Assessment |
|
| Multiple Sclerosis Relapse | Nervous system disorders | MedDRA® Version 24.1 | Non-systematic Assessment |
|
| Sleep Disorder | Psychiatric disorders | MedDRA® Version 24.1 | Non-systematic Assessment |
|
| Dry Skin | Skin and subcutaneous tissue disorders | MedDRA® Version 24.1 | Non-systematic Assessment |
|
| Anaemia | Blood and lymphatic system disorders | MedDRA® Version 24.1 | Non-systematic Assessment |
|
| Lymphopenia | Blood and lymphatic system disorders | MedDRA® Version 24.1 | Non-systematic Assessment |
|
| Vaginal Infection | Infections and infestations | MedDRA® Version 24.1 | Non-systematic Assessment |
|
| Blood Pressure Increased | Investigations | MedDRA® Version 24.1 | Non-systematic Assessment |
|
| Neck Pain | Musculoskeletal and connective tissue disorders | MedDRA® Version 24.1 | Non-systematic Assessment |
|
| Oropharyngeal Pain | Respiratory, thoracic and mediastinal disorders | MedDRA® Version 24.1 | Non-systematic Assessment |
|
| Vertigo | Ear and labyrinth disorders | MedDRA® Version 24.1 | Non-systematic Assessment |
|
| Eye Pruritus | Eye disorders | MedDRA® Version 24.1 | Non-systematic Assessment |
|
| Lacrimation Increased | Eye disorders | MedDRA® Version 24.1 | Non-systematic Assessment |
|
| Vision Blurred | Eye disorders | MedDRA® Version 24.1 | Non-systematic Assessment |
|
| Abdominal Pain Upper | Gastrointestinal disorders | MedDRA® Version 24.1 | Non-systematic Assessment |
|
| Diarrhoea | Gastrointestinal disorders | MedDRA® Version 24.1 | Non-systematic Assessment |
|
| Nausea | Gastrointestinal disorders | MedDRA® Version 24.1 | Non-systematic Assessment |
|
| Toothache | Gastrointestinal disorders | MedDRA® Version 24.1 | Non-systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | MedDRA® Version 24.1 | Non-systematic Assessment |
|
| Asthenia | General disorders | MedDRA® Version 24.1 | Non-systematic Assessment |
|
| Pyrexia | General disorders | MedDRA® Version 24.1 | Non-systematic Assessment |
|
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA® Version 24.1 | Non-systematic Assessment |
|
| Tooth Fracture | Injury, poisoning and procedural complications | MedDRA® Version 24.1 | Non-systematic Assessment |
|
| Alanine Aminotransferase Increased | Investigations | MedDRA® Version 24.1 | Non-systematic Assessment |
|
| Blood Creatine Phosphokinase MB Increased | Investigations | MedDRA® Version 24.1 | Non-systematic Assessment |
|
| Low Density Lipoprotein Increased | Investigations | MedDRA® Version 24.1 | Non-systematic Assessment |
|
| Weight Decreased | Investigations | MedDRA® Version 24.1 | Non-systematic Assessment |
|
| Joint Swelling | Musculoskeletal and connective tissue disorders | MedDRA® Version 24.1 | Non-systematic Assessment |
|
| Myalgia | Musculoskeletal and connective tissue disorders | MedDRA® Version 24.1 | Non-systematic Assessment |
|
| Hypoaesthesia | Nervous system disorders | MedDRA® Version 24.1 | Non-systematic Assessment |
|
| Meralgia Paraesthetica | Nervous system disorders | MedDRA® Version 24.1 | Non-systematic Assessment |
|
| Dyspnoea | Respiratory, thoracic and mediastinal disorders | MedDRA® Version 24.1 | Non-systematic Assessment |
|
| Epistaxis | Respiratory, thoracic and mediastinal disorders | MedDRA® Version 24.1 | Non-systematic Assessment |
|
| Rash | Skin and subcutaneous tissue disorders | MedDRA® Version 24.1 | Non-systematic Assessment |
|
Not provided
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |
| D003839 | Deoxyadenosines |
| D003853 | Deoxyribonucleosides |
| D009705 | Nucleosides |
| D009706 | Nucleic Acids, Nucleotides, and Nucleosides |
| D012263 | Ribonucleosides |
| Title | Measurements |
|---|---|
|
| Day 13 |
|
| Title | Measurements |
|---|---|
|
| Day 13 |
|