Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

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

This study aims to understand how a standard combined contraceptive pill is handled by the body, both on its own and when taken together with a new medicine called GSK3036656. GSK3036656 is being developed to treat tuberculosis. The study is for women aged 18 and older who are no longer able to have children. It's a very early-stage study, meaning researchers are mainly checking how the medicines interact and how safe they are. This information is important for knowing how women taking both medicines might be affected and to ensure future treatments are safe and effective.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Glaxosmithkline Research & Development Limited

Enrolment target

Start

23 Feb 2024

Tuberculosis

What is this study about?

This study is taking place because researchers need to understand how different medicines interact within the body. Specifically, they want to see if a new medicine called GSK3036656, which is being developed to treat tuberculosis, affects how a common combined contraceptive pill works.

When you take different medications at the same time, they can sometimes influence each other. One medicine might make the other one more or less effective, or it could change how your body processes it. This study is designed to carefully observe these interactions.

The findings from this research are really important. They will help doctors and researchers understand if women taking medication for tuberculosis would need to adjust their contraceptive pill, or if doctors need to be aware of any changes in how the pill works. This early stage research helps make sure that any new medicines can be used safely and effectively by everyone who needs them.

Key takeaways

This study looks at how a contraceptive pill and a new TB medicine interact.
It's for women aged 18+ who can't have children anymore.
The main goal is to understand how the body handles these medicines.
The results will help ensure future treatments are safe and effective.
Participation involves clinic visits and health checks.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for women who are 18 years old or older. You should be past childbirth, meaning you are no longer able to have children, for example, if you have gone through menopause or had a procedure like a hysterectomy.

To join, you must be in good general health. The study team will check your medical history and do some tests to make sure it's safe for you to take part.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you a woman aged 18 or older?
Are you no longer able to get pregnant (non-childbearing potential)?
Are you generally in good health?
Are you able to attend several clinic appointments?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be given the combined contraceptive pill, either on its own or with the experimental medicine GSK3036656, depending on which group you're in. This is a "Phase I" study, which means it carefully checks how the body handles the medicines. You will need to attend several appointments at the study site, where you'll have blood tests, urine tests, and health checks. You will likely spend a few nights at the clinic during the study period. The exact number of visits and the full duration of your involvement will be clearly explained by the study team.

Potential risks and benefits

Taking part in a study like this might offer a benefit by contributing to medical knowledge that could help future patients. However, there's no direct personal health benefit expected for you. There are potential risks associated with any medication, including side effects from the contraceptive pill or the experimental medicine, and risks from procedures like blood tests. All potential risks will be thoroughly explained before you decide to join. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Spain

Common questions

What is tuberculosis?

Tuberculosis (TB) is a serious infection, usually of the lungs, caused by bacteria. It can be treated with medicines.

What is a combined oral contraceptive?

It's often called 'the pill'. It's a type of birth control that women take daily to prevent pregnancy, containing two types of hormones.

What does 'non-childbearing potential' mean?

It means you are no longer able to get pregnant. This could be due to menopause, having had certain medical procedures, or other reasons.

Why do they need to study these medicines together?

Researchers need to know if the new tuberculosis medicine changes how the contraceptive pill works in the body, to make sure both can be used safely.

Will I get paid for taking part?

Some studies offer payment for your time and expenses. You should ask the study team about this.