TuberculosisPhase 1NCT06354257
A Study to Investigate the Pharmacokinetics of a Combined Oral Contraceptive When Given Alone and in Combination With GSK3036656 in Female Participants of Non-childbearing Potential Aged 18 to 65 Years of Age
A Phase 1 study testing Microgynon and GSK3036656 in people with Tuberculosis, run by GlaxoSmithKline at 1 site in Spain.
Trial summary
The purpose of this study is to provide data showing if there are any effects of GSK3036656 on a combined oral contraceptive containing Ethinyl Estradiol (EE) and Levonorgestrel (LNG), which will help inform future studies on suitable contraceptive measures to be used. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Tuberculosis
- What is being tested?
- Microgynon and GSK3036656
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteSpain
- Study dates
- 5 Apr 2024to 1 Jul 2024
- Phase
- Phase 1
- 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 65 years
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age:
- Participant was 18 to 65 years of age, inclusive, at the time of signing the informed consent.
- Type of Participant and Disease Characteristics:
- Participants were healthy or compensated, as determined by the investigator or medically qualified designee, based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring (history and ECG).
- Creatinine clearance was >= 75 mL/min.
- Echocardiogram was normal or showed normal left ventricular function; at most trace to mild valvular regurgitation was allowed, with no valvular stenosis.
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- Weight:
- Body weight was >= 45.0 kg (99 lbs), and body mass index was within the range 18.5 to 31.0 kg/m² (inclusive).
- Sex:
- Female participants were of Nonchildbearing Potential (WONCBP).
- Women in the following categories were considered WONCBP:
- Permanently sterile due to one of the following procedures:
- Documented hysterectomy.
- Documented bilateral salpingectomy.
- Documented bilateral oophorectomy.
- Postmenopausal females. A postmenopausal state was defined as no menses for 12 months without an alternative medical cause.
- A high follicle-stimulating hormone (FSH) level in the postmenopausal range could have been used to confirm a postmenopausal state in women not using hormonal contraception or hormone replacement therapy (HRT). However, in the absence of 12 months of amenorrhea, confirmation with >1 FSH measurement was required within the screening period.
- Females on HRT and whose menopausal status was in doubt discontinued HRT >= 30 days prior to the start of Treatment Period 1 to allow confirmation of postmenopausal status before study enrolment.
- Informed Consent:
- Participant was capable of giving signed informed consent, which included compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol.
Who cannot join
- Medical History:
- History of known cardiac valve abnormalities.
- Laboratory Assessments:
- Presence of hepatitis B surface antigen at Screening or within 3 months prior to starting study treatment.
- Positive hepatitis C antibody test result at Screening or within 3 months prior to starting study treatment, and positive on reflex to hepatitis C RNA.
- Positive HIV-1 and -2 antigen/antibody immunoassay at Screening.
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- Alanine aminotransferase (ALT) > 1.5×ULN. A single repeat of ALT was allowed within a single screening period to determine eligibility.
- Bilirubin > 1.5×ULN (isolated bilirubin > 1.5×ULN was acceptable if bilirubin was fractionated and direct bilirubin was < 35%).
- Any acute laboratory abnormality at Screening which, in the opinion of the investigator, should have precluded participation in the study of an investigational compound.
- Participants with haemoglobin < 8.0 g/dL.
- Any Grade 2 to 4 laboratory abnormality at Screening-except creatine phosphokinase, lipid abnormalities, and ALT (as above)-excluded a participant unless the investigator provided a compelling explanation and had sponsor assent. A single repeat of any laboratory abnormality was allowed within a single screening period.
- Positive test result for drugs of abuse (including marijuana), alcohol, or cotinine at Screening or before the first study dose.
- Prior/Concomitant Therapy:
- Participants were unable to refrain from using prescription or non-prescription drugs, including vitamins, herbal and dietary supplements (including St John's wort), within 7 days prior to the first dose and throughout the study.
- Levothyroxine and omeprazole were allowed if participants had been on a stable dose for >= 1 month prior to Treatment Period 1 and maintained the same dose. Microgynon was administered >= 1 hour after levothyroxine or omeprazole. Other medications were allowed on a case-by-case basis with medical monitor and GSK ganfeborole team approval.
- Participants received any vaccine within 30 days prior to study treatment.
- Participants were unwilling to abstain from excessive consumption of caffeine, grapefruit, grapefruit juice, Seville oranges, blood oranges, pomelos, or their juices within 7 days prior to first dose through study end.
- Participants who had undergone IVF or assisted reproductive techniques within 9 months prior to screening, were currently participating, or planned such procedures during the following year were excluded.
- Prior/Concurrent Clinical Study Experience:
- Participants had taken part in another clinical study within 30 days, 5 half-lives + 10 days, or 2× duration of the investigational product's biological effect (whichever was longer).
- Study participation resulted in donation of blood or blood products > 500 mL within 56 days.
- Diagnostic Assessments:
- Significant arrhythmia or ECG findings, in the opinion of the investigator or GSK Medical Monitor, would have interfered with participant safety.
- Exclusion criteria for screening ECG:
- Heart rate < 50 or > 100 bpm
- QTcF interval > 450 ms
- Other Exclusion Criteria:
- Participants with vitiligo.
- Participants with hypertension or Type 2 diabetes that could not be controlled with diet and exercise alone.
- History of regular alcohol consumption within 6 months of the study, defined as an average weekly intake > 14 units.
- Use of tobacco- or nicotine-containing products within 3 months prior to Screening.
- History of sensitivity to any study medications or components, or any allergy that, in the investigator's or medical monitor's opinion, contraindicated participation.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1, Open-label, Fixed Sequence, 1-way Drug-drug Interaction Study to Investigate the Pharmacokinetics of GSK3036656 and an Oral Contraceptive Containing Ethinyl Estradiol and Levonorgestrel When the Oral Contraceptive is Administered Alone and in Combination With GSK3036656 in Healthy Female Participants of Nonchildbearing Potential Aged 18-65 Years of Age
The purpose of this study is to provide data showing if there are any effects of GSK3036656 on a combined oral contraceptive containing Ethinyl Estradiol (EE) and Levonorgestrel (LNG), which will help inform future studies on suitable contraceptive measures to be used.
- Conditions
- Tuberculosis
- Being tested
- Microgynon, GSK3036656
- Keywords
- Oral contraceptive, GSK3036656, Fixed sequence, Ethinyl Estradiol, Levonorgestrel, Drug interaction
- Medical subject headings
- Tuberculosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MicrogynonDrug
Participants received 1 dose of Microgynon (0.03 mg EE/0.15 mg LNG) on Day 1 of Treatment Period 1 and 1 dose co-administered with GSK3036656 20 mg on Day 15 of Treatment Period 3.
GSK3036656Drug
Participants received 1 loading dose of 40 mg on Day 4 and a dose of 20 mg on Days 5 to 14 once daily in Treatment Period 2. In Treatment Period 3, participants received one 20 mg dose along with Microgynon (0.03 mg EE/0.15 mg LNG) on Day 15 after which a 20 mg dose on Days 17 and 18 once daily.
| Study group | Role | What they receive |
|---|---|---|
| Combined Participants Group | Experimental | Participants received a dose of Microgynon [0.03 mg Ethinyl Estradiol (EE)/0.15 mg Levonorgestrel (LNG)] on Day 1 of Treatment Period 1. In Treatment Period 2, they received GSK3036656 40 mg on Day 4 followed by GSK3036656 20 mg once daily from Day 5 to Day 14. In Treatment Period 3, participants received Microgynon (EE/LNG) along with GSK3036656 20 mg on Day 15, followed by GSK3036656 20 mg once daily from Day 16 to Day 17. Receives: Drug: Microgynon; Drug: GSK3036656 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Area Under the Plasma Drug Concentration (AUC) From Time Zero Extrapolated to Infinity (AUC[0-inf]) After a Single Dose of EE and LNG
AUC(0-inf) is defined as the area under the concentration-time curve from time 0 extrapolated to infinity and was calculated by using a non-compartmental analysis.
Measured: At Day 1 for the Treatment Period 1: Microgynon Group and at Day 15 for the Treatment Period 3: Microgynon + GSK3036656 Group
Maximum Observed Plasma Concentration (Cmax) After a Single Dose of EE and LNG
Cmax is defined as the maximum observed plasma concentration determined directly from the concentration-time data and was calculated by using a non-compartmental analysis.
Measured: At Day 1 for the Treatment Period 1: Microgynon Group and at Day 15 for the Treatment Period 3: Microgynon + GSK3036656 Group
Secondary outcomes (16)
AUC Versus Time Curve From Time Zero During a Dosage Interval of Time at Steady State [AUC(0-tau)] of GSK3036656 With EE/LNG
AUC(0-tau) is defined as the area under the concentration-time curve over a dosing interval and was calculated by using a non-compartmental analysis.
Measured: At Day 15
Cmax at Steady State of GSK3036656 With EE/LNG
Cmax is defined as the maximum observed plasma concentration determined directly from the concentration-time data and was calculated by using a non-compartmental analysis.
Measured: At Day 15
Trough Plasma Concentration (Ctau) at Steady State of GSK3036656 With EE/LNG and GSK3036656 Alone
Ctau is defined as the concentration reached by the drug immediately before the next dose is administered.
Measured: At Day 8, 10, 12, 15 and 16
Time to Maximum Observed Plasma Drug Concentration (Tmax) at Steady State of GSK3036656 With EE/LNG
Tmax is defined as a measure of the time required to reach the maximum concentration of the drug, determined directly from the concentration-time data.
Measured: At Day 15
AUC Versus Time Curve (AUC[0-t]) of EE and LNG Alone and With GSK3036656
AUC(0-t) is defined as area under the plasma drug concentration versus time curve from time zero (pre-dose) to last time of quantifiable concentration and was calculated by using a non-compartmental analysis.
Measured: At Day 1 for the Treatment Period 1: Microgynon Group and at Day 15 for the Treatment Period 3: Microgynon + GSK3036656 Group
Tmax of EE and LNG Alone and With GSK3036656
Tmax is defined as a measure of the time required to reach the maximum concentration of the drug, determined directly from the concentration-time data.
Measured: At Day 1 for the Treatment Period 1: Microgynon Group and at Day 15 for the Treatment Period 3: Microgynon + GSK3036656 Group
Apparent Terminal Half-life (t1/2) of EE and LNG Alone and With GSK3036656
t1/2 is defined as the time required by the plasma concentration to decline by 50% and was calculated by using a non-compartmental analysis.
Measured: At Day 1 for the Treatment Period 1: Microgynon Group and at Day 15 for the Treatment Period 3: Microgynon + GSK3036656 Group
Number of Participants With Serious Adverse Events (SAEs)
A SAE is defined as any untoward medical occurrence that, at any dose: resulted in death, was life threatening, required hospitalization or prolongation of existing hospitalization, resulted in disability/incapacity, congenital anomaly/birth defect or any other situation according to medical or scientific judgment.
Measured: From the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) up to Day 18
Number of Participants With Grade 3 or Higher Severity Adverse Events (AEs)
The intensity of AEs was assessed using the Division of Acquired Immunodeficiency Syndrome (DAIDS) criteria Version 2.1 where grades are defined based on numeric criteria as follows Grade 3: severe or medically significant; Grade 4: potentially life-threatening; Grade 5: death. A higher grade indicates greater severity.
Measured: From Day 1 up to Day 18
Number of Participants With Drug-related AEs Following Administration of Microgynon and Following the Administration of GSK3036656
The drug-related AEs were assessed by the investigator to be possibly, probably or definitely related to the study interventions.
Measured: From Day 1 up to Day 18
Number of Participants Withdrawn From the Treatment Due to AEs
Adverse events resulting in withholding of study intervention administration were included in this outcome measure.
Measured: From Day 1 up to Day 18
Number of Participants Withdrawn From the Study Due to AEs
Measured: From Day 1 up to Day 18
Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Importance (PCI)
PCI ECG values are defined as any ECG findings which, in the opinion of the investigator or medical monitor would interfere with the safety of the individual participant. The ECG measurements analyzed are PR Interval, QRS Duration, and QTcF Interval. A value was reported as "high" for a period if it shifted from "low" or "within range" (W/in) at the start of the treatment period but was "high" during or at the end of the same treatment period. A value was reported as "low" for a period if it shifted from "high" or "W/in" at the start of the treatment period but was "low" during or at the end of the same treatment period. A value was reported as "No Change" if it remained unchanged (e.g. High to High), or as "To W/in Range" if it was within range.
Measured: From Day 1 up to Day 18
Number of Participants With Clinical Chemistry Laboratory Values of PCI
The chemistry parameters analyzed are homocysteine, alanine aminotransferase (ALT), aspartate aminotransferase (AST), direct bilirubin, bilirubin, calcium, creatine kinase, potassium, protein, sodium, urea, and glucose. A value was reported as "high" for a period if it shifted from "low" or "within range" (W/in) at the start of the treatment period but was "high" during or at the end of the same treatment period. A value was reported as "low" for a period if it shifted from "high" or "W/in" at the start of the treatment period but was "low" during or at the end of the same treatment period. A value was reported as "No Change" if it remained unchanged (e.g. High to High), or as "To W/in Range" if it was within range.
Measured: From Day 1 up to Day 18
Number of Participants With Haematology Laboratory Values of PCI
The analyzed hematology parameters are reticulocytes/erythrocytes, monocytes/leukocytes, erythrocytes, basophils/leukocytes, eosinophils/leukocytes, mean corpuscular hemoglobin, hematocrit, hemoglobin, lymphocytes, neutrophils, and platelets. A value was reported as "high" for a period if it shifted from "low" or "within range" (W/in) at the start of the treatment period but was "high" during or at the end of the same treatment period. A value was reported as "low" for a period if it shifted from "high" or "W/in" at the start of the treatment period but was "low" during or at the end of the same treatment period. A value was reported as "No Change" if it remained unchanged (e.g. High to High), or as "To W/in Range" if it was within range.
Measured: From Day 1 up to Day 18
Number of Participants With Vital Signs Parameters of PCI
The analyzed vital signs are systolic blood pressure, diastolic blood pressure, heart rate, body temperature, and respiration rate. A value was reported as "high" for a period if it shifted from "low" or "within range" (W/in) at the start of the treatment period but was "high" during or at the end of the same treatment period. A value was reported as "low" for a period if it shifted from "high" or "W/in" at the start of the treatment period but was "low" during or at the end of the same treatment period. A value was reported as "No Change" if it remained unchanged (e.g. High to High), or as "To W/in Range" if it was within range.
Measured: From Day 1 up to Day 18
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2024
- Study start5 Apr 2024
- Primary completion1 Jul 2024
- Study completion1 Jul 2024
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.
- Other trials for TuberculosisStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe 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 1
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Model description
- Fixed sequence
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06354257
- Sponsor's protocol ID
- 220104
- Status last verified
- Aug 2025
- First submitted
- 3 Apr 2024
- Last updated
- 26 Aug 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: GSK will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About\_GSK\_Patient\_Level\_Data\_Sharing\_Final\_13July2023.pdf.
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Open-label, Fixed Sequence, 1-way Drug-drug Interaction Study to Investigate the Pharmacokinetics of GSK3036656 and an Oral Contraceptive Containing Ethinyl Estradiol and Levonorgestrel When the Oral Contraceptive is Administered Alone and in Combination With GSK3036656 in Healthy Female Participants of Nonchildbearing Potential Aged 18-65 Years of Age
- ClinicalTrials.gov ID
- NCT06354257
- Acronym / sponsor ID
- 220104
- Conditions
- Tuberculosis
- Keywords
- Oral contraceptive, GSK3036656, Fixed sequence, Ethinyl Estradiol, Levonorgestrel, Drug interaction
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 5 Apr 2024 (actual)
- Primary completion
- 1 Jul 2024 (actual)
- Study completion
- 1 Jul 2024 (actual)
- First posted
- 9 Apr 2024 (actual)
- Results
- Posted 26 Aug 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to provide data showing if there are any effects of GSK3036656 on a combined oral contraceptive containing Ethinyl Estradiol (EE) and Levonorgestrel (LNG), which will help inform future studies on suitable contraceptive measures to be used.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Fixed sequence
| Arm | Type | Receives |
|---|---|---|
| Combined Participants Group | Experimental | Drug: Microgynon, Drug: GSK3036656Participants received a dose of Microgynon [0.03 mg Ethinyl Estradiol (EE)/0.15 mg Levonorgestrel (LNG)] on Day 1 of Treatment Period 1. In Treatment Period 2, they received GSK3036656 40 mg on Day 4 followed by GSK3036656 20 mg once daily from Day 5 to Day 14. In Treatment Period 3, participants received Microgynon (EE/LNG) along with GSK3036656 20 mg on Day 15, followed by GSK3036656 20 mg once daily from Day 16 to Day 17. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- Participant was 18 to 65 years of age, inclusive, at the time of signing the informed consent.
- Participants were healthy or compensated, as determined by the investigator or medically qualified designee, based on a medical evaluation including medical history, physical examination, laboratory tests, and cardiac monitoring (history and ECG).
- Creatinine clearance was >= 75 mL/min.
- Echocardiogram was normal or showed normal left ventricular function; at most trace to mild valvular regurgitation was allowed, with no valvular stenosis.
- Body weight was >= 45.0 kg (99 lbs), and body mass index was within the range 18.5 to 31.0 kg/m² (inclusive).
Key exclusion criteria (32 listed)
- History of known cardiac valve abnormalities.
- Presence of hepatitis B surface antigen at Screening or within 3 months prior to starting study treatment.
- Positive hepatitis C antibody test result at Screening or within 3 months prior to starting study treatment, and positive on reflex to hepatitis C RNA.
- Positive HIV-1 and -2 antigen/antibody immunoassay at Screening.
- Alanine aminotransferase (ALT) > 1.5×ULN. A single repeat of ALT was allowed within a single screening period to determine eligibility.
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 |
|---|---|---|
| MicrogynonParticipants received 1 dose of Microgynon (0.03 mg EE/0.15 mg LNG) on Day 1 of Treatment Period 1 and 1 dose co-administered with GSK3036656 20 mg on Day 15 of Treatment Period 3. | Drug | Combined Participants Group |
| GSK3036656Participants received 1 loading dose of 40 mg on Day 4 and a dose of 20 mg on Days 5 to 14 once daily in Treatment Period 2. In Treatment Period 3, participants received one 20 mg dose along with Microgynon (0.03 mg EE/0.15 mg LNG) on Day 15 after which a 20 mg dose on Days 17 and 18 once daily. | Drug | Combined Participants Group |
Primary outcome
Area Under the Plasma Drug Concentration (AUC) From Time Zero Extrapolated to Infinity (AUC[0-inf]) After a Single Dose of EE and LNG
Time frame: At Day 1 for the Treatment Period 1: Microgynon Group and at Day 15 for the Treatment Period 3: Microgynon + GSK3036656 Group
AUC(0-inf) is defined as the area under the concentration-time curve from time 0 extrapolated to infinity and was calculated by using a non-compartmental analysis.
Maximum Observed Plasma Concentration (Cmax) After a Single Dose of EE and LNG
Time frame: At Day 1 for the Treatment Period 1: Microgynon Group and at Day 15 for the Treatment Period 3: Microgynon + GSK3036656 Group
Cmax is defined as the maximum observed plasma concentration determined directly from the concentration-time data and was calculated by using a non-compartmental analysis.
16 secondary outcomes
AUC Versus Time Curve From Time Zero During a Dosage Interval of Time at Steady State [AUC(0-tau)] of GSK3036656 With EE/LNG
Time frame: At Day 15
Cmax at Steady State of GSK3036656 With EE/LNG
Time frame: At Day 15
Trough Plasma Concentration (Ctau) at Steady State of GSK3036656 With EE/LNG and GSK3036656 Alone
Time frame: At Day 8, 10, 12, 15 and 16
Time to Maximum Observed Plasma Drug Concentration (Tmax) at Steady State of GSK3036656 With EE/LNG
Time frame: At Day 15
AUC Versus Time Curve (AUC[0-t]) of EE and LNG Alone and With GSK3036656
Time frame: At Day 1 for the Treatment Period 1: Microgynon Group and at Day 15 for the Treatment Period 3: Microgynon + GSK3036656 Group
Tmax of EE and LNG Alone and With GSK3036656
Time frame: At Day 1 for the Treatment Period 1: Microgynon Group and at Day 15 for the Treatment Period 3: Microgynon + GSK3036656 Group
Apparent Terminal Half-life (t1/2) of EE and LNG Alone and With GSK3036656
Time frame: At Day 1 for the Treatment Period 1: Microgynon Group and at Day 15 for the Treatment Period 3: Microgynon + GSK3036656 Group
Number of Participants With Serious Adverse Events (SAEs)
Time frame: From the signing of the informed consent form (a period starting up to 14 days before the first dose on Day 1) up to Day 18
Number of Participants With Grade 3 or Higher Severity Adverse Events (AEs)
Time frame: From Day 1 up to Day 18
Number of Participants With Drug-related AEs Following Administration of Microgynon and Following the Administration of GSK3036656
Time frame: From Day 1 up to Day 18
Number of Participants Withdrawn From the Treatment Due to AEs
Time frame: From Day 1 up to Day 18
Number of Participants Withdrawn From the Study Due to AEs
Time frame: From Day 1 up to Day 18
Number of Participants With Electrocardiogram (ECG) Values of Potential Clinical Importance (PCI)
Time frame: From Day 1 up to Day 18
Number of Participants With Clinical Chemistry Laboratory Values of PCI
Time frame: From Day 1 up to Day 18
Number of Participants With Haematology Laboratory Values of PCI
Time frame: From Day 1 up to Day 18
Number of Participants With Vital Signs Parameters of PCI
Time frame: From Day 1 up to Day 18
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Yes. GSK will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/About_GSK_Patient_Level_Data_Sharing_Final_13July2023.pdf.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Microgynon and GSK3036656 in people with Tuberculosis, run by GlaxoSmithKline at 1 site in Spain.
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 20 inclusion and 32 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 26 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. 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 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?
Yes. Results are posted in the registry (first posted 26 Aug 2025). 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?
Area Under the Plasma Drug Concentration (AUC) From Time Zero Extrapolated to Infinity (AUC[0-inf]) After a Single Dose of EE and LNG (time frame: At Day 1 for the Treatment Period 1: Microgynon Group and at Day 15 for the Treatment Period 3: Microgynon + GSK3036656 Group). The study lists 2 primary outcomes in all. 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 26 Aug 2025.