A Study to Investigate the Pharmacokinetics of a Combined Oral Contraceptive When Given Alone and… (NCT06354257) | Clinical Trial Compass
CompletedPhase 1
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
Spain20 participantsStarted 2024-04-05
Plain-language 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.
Who can participate
Age range
18 Years – 65 Years
Sex
FEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. 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).
. Female participants were of Nonchildbearing Potential (WONCBP).
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Area Under the Plasma Drug Concentration (AUC) From Time Zero Extrapolated to Infinity (AUC[0-inf]) After a Single Dose of EE and LNG
Timeframe: At Day 1 for the Treatment Period 1: Microgynon Group and at Day 15 for the Treatment Period 3: Microgynon + GSK3036656 Group
2
Maximum Observed Plasma Concentration (Cmax) After a Single Dose of EE and LNG
Timeframe: At Day 1 for the Treatment Period 1: Microgynon Group and at Day 15 for the Treatment Period 3: Microgynon + GSK3036656 Group
. 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.
. 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.