Evaluation of the bioequivalence of two intravaginal gel preparations containing 90 mg progesterone
This clinical trial is comparing two different vaginal gels that each contain 90 mg of progesterone. Progesterone is a hormone often used in fertility treatments and hormone replacement therapy. When a company makes a new version of an existing medicine, they must prove that it is 'bioequivalent'. This means the body absorbs it in the exact same way and amount as the trusted version already available on the NHS. Because this is an early-stage study, the researchers are looking for healthy female volunteers aged 18 and older rather than patients with a medical condition. Participants will receive both gels at different times, and doctors will take regular blood samples to measure hormone levels. Taking part helps ensure that patients have access to safe, effective, and potentially more affordable treatment options in the future.
At a glance
What is this study about?
Progesterone is a naturally occurring hormone that plays a vital role in the body, particularly in the menstrual cycle, fertility, and pregnancy. Doctors often prescribe progesterone as an intravaginal gel—a soft gel placed inside the vagina using an applicator—for women having fertility treatments or needing hormone support.
This trial is known as a bioequivalence study. When a medicine has been used successfully for a long time, other manufacturers may develop their own versions. Before a new brand can be approved for doctors to prescribe, scientists must confirm that it works just as well as the original. This trial compares a new progesterone gel against an established one to confirm that the body absorbs both in the same way.
Because the goal is simply to measure how the medicine moves through the body, this trial does not aim to treat an illness. Instead, it involves healthy adult volunteers. By testing the gels in healthy individuals, researchers can clearly see the effects of the medicine without interference from other health conditions or ongoing treatments.
Studies like this are an essential step in bringing new medicines to the public. If the new gel works identically to the established one, it can give the NHS and patients more treatment choices, which often helps lower healthcare costs.
Key takeaways
- This study compares two different brands of 90 mg progesterone vaginal gel.
- It aims to prove that a new gel behaves the same way in the body as an approved one.
- The trial is open to healthy adult women aged 18 and older.
- Participants will need to attend clinic visits and give blood samples so hormone levels can be measured.
- Taking part helps make safe, alternative medicines available on the NHS.
Who may be eligible?
This study is designed for healthy adult women aged 18 and older. Because the goal is to observe how the body naturally absorbs the gel, volunteers must generally be in good health with no major ongoing medical conditions.
To ensure the results are clear and safe, participants usually cannot be pregnant, breastfeeding, or planning a pregnancy during the trial. You may also be asked about your menstrual cycle and any medicines you take, as some hormonal medications or vaginal treatments could interfere with the study results.
Before joining, you will have a health check with the study team. They will review your medical history, carry out standard checks like blood pressure and blood tests, and confirm whether the study is a safe fit for you.
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.
- I am a woman aged 18 or older.
- I consider myself to be in good general health.
- I am not currently pregnant or breastfeeding.
- I am comfortable using a vaginal gel applicator.
- I am willing to attend clinic visits and have regular blood tests.
What does participation involve?
Taking part in this study involves visiting a specialist clinical research unit. Because it compares two gels, it is usually a 'crossover' study. This means you will use one gel during the first part of the study, have a rest period of a few weeks so the medicine fully leaves your system, and then use the other gel.
During each study period, the gel will be applied inside the vagina. You will likely spend some time at the clinic—sometimes including an overnight stay—so the medical team can take blood samples at set times. These blood tests show how quickly and effectively the progesterone enters your bloodstream.
The research staff will monitor you closely for any side effects and check your vital signs throughout. The overall study usually lasts several weeks from your initial screening visit to a final follow-up check.
Potential risks and benefits
Locations (1)
- —UnverifiedBulgaria
Common questions
What does bioequivalence mean?
Bioequivalence means that two medicines contain the same active ingredient and produce the exact same levels of that medicine in the body, proving they are equally safe and effective.
Will this study treat any condition I have?
No. This trial is for healthy volunteers and is designed only to measure how the medicine is absorbed, not to treat a condition.
Are travel expenses covered?
Phase I studies with healthy volunteers typically provide compensation for your time and inconvenience, and cover travel costs. The study team can give you exact details.
Is the gel painful to use?
No, it is applied with a smooth, pre-filled applicator similar to a tampon. It should not hurt, though some women notice slight temporary irritation.
Can I stop taking part if I change my mind?
Yes, taking part is entirely voluntary. You can withdraw from the study at any time without needing an explanation.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
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