RecruitingNAINTERVENTIONAL

Evolution of Sexual Life Quality of Women With POI Before and After Introduction of Hormone Replacement Therapy

This study investigates how hormone replacement therapy (HRT) impacts the sexual well-being of women diagnosed with premature ovarian insufficiency (POI), sometimes called premature menopause. POI occurs when a woman's ovaries stop working normally before the age of 40. This can lead to various symptoms, including changes in sex drive, vaginal dryness, and discomfort during sex. The study wants to understand if and how these issues improve after women start HRT. Researchers will use a special survey (the FSFI scale) to measure changes in sexual quality of life before and after starting treatment. This information could help doctors better support women with POI and encourage them to continue with their treatment.

At a glance

Status

Recruiting

Phase

Sponsor

University Hospital, Bordeaux

Enrolment target

135

Start

17 Jul 2023

Estimated completion

01 Jun 2027

Premature Ovarian Failure

What is this study about?

This study is about a condition called Premature Ovarian Insufficiency (POI), which affects about 1-2 out of every 100 women before they turn 40. It's when the ovaries stop working as they should, leading to lower levels of certain hormones, especially oestrogen. This can cause a range of symptoms, including changes in a woman's sex life. For example, some women might notice a lower sex drive, vaginal dryness, or discomfort during sex. These issues can have a big impact on a woman's overall quality of life.

Doctors often prescribe hormone replacement therapy (HRT) to help manage the symptoms of POI. We know that HRT can help with many of these symptoms. In the past, research has shown that women with POI who are on HRT might have a better sex life than those not on treatment, though it might still be different from women whose ovaries are working normally. However, we don't have much information about how a woman's sexual well-being changes specifically before and after she starts taking HRT.

This study aims to fill that gap. By looking at how women's experiences change after starting HRT, the researchers hope to understand more about the benefits of this treatment for sexual health. This kind of information is really important because it can help doctors explain the benefits of HRT more clearly. It could also encourage women to stick with their treatment, knowing that it might improve their sexual quality of life, alongside other benefits.

Key takeaways

The study explores how HRT affects sexual quality of life for women with POI.
It uses simple questionnaires to gather information.
Participation involves no new medications or extra doctor visits.
The goal is to provide better information for women and healthcare professionals.
Results could help improve understanding of HRT benefits for quality of life.

Who may be eligible?

To join this study, you need to be a woman between 18 and 40 years old. You must have been diagnosed with Premature Ovarian Insufficiency (POI). This diagnosis means you've had no periods, or very infrequent periods, for at least four months, and blood tests have twice shown high levels of a hormone called FSH, at least four weeks apart. Importantly, you shouldn't be taking any hormone treatments when you join the study.

Before taking part, you'll need to give your verbal permission, and you must have health insurance or be covered by the relevant health system. The study organisers will make sure you understand what the study involves before you agree to participate.

You won't be able to join if you have certain health conditions that would make hormone treatment unsafe for you, such as a history of certain types of cancer or a previous stroke caused by a blocked blood vessel. Also, if you're unable to understand what the study is about or if you are under legal guardianship, you won't be able 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 between 18 and 40 years old?
Have you been diagnosed with Premature Ovarian Insufficiency (POI) by a doctor?
Are you not currently taking any hormone treatments?
Do you have a clear understanding of what participation involves?
Do you not have a history of certain cancers or a stroke?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, it would mainly involve answering questions through a survey. You would complete a questionnaire about your sexual health and quality of life before you start hormone replacement therapy (HRT). Then, after you've been on HRT for a period, you would complete the same questionnaire again. The study is focused on observing the impact of HRT, which your doctor would prescribe as part of your usual care, so there are no new medications given specifically for the study. There are no additional hospital visits beyond what your doctor would normally recommend. The total duration of your participation would depend on when you complete the questionnaires before and after starting HRT, as decided with your healthcare team.

Potential risks and benefits

Taking part in this study could help us all understand more about how hormone replacement therapy (HRT) can improve the quality of life for women with Premature Ovarian Insufficiency (POI). There are no direct medical risks from participating in the study itself, as it only involves completing questionnaires and doesn't change your medical treatment. Your doctor will discuss the potential benefits and risks of HRT with you as part of your regular medical care. Remember, you have the right to withdraw from the study at any time without giving a reason, and this won't affect your medical care.

Locations (1)

CHU Bordeaux
Verified postcode
Bordeaux, France· Recruiting

Common questions

What is Premature Ovarian Insufficiency (POI)?

POI is when a woman's ovaries stop working normally before the age of 40, leading to a decrease in hormones like oestrogen. It's sometimes called premature menopause.

What is Hormone Replacement Therapy (HRT)?

HRT is a treatment that replaces the hormones your body is no longer producing. It can help manage symptoms linked to POI, including those affecting sexual health.

Will I have to take new medicine for this study?

No, this study doesn't involve giving you new medicine. It observes the effects of HRT, which your doctor would prescribe as part of your usual treatment.

How long will I be in the study?

Your participation will involve completing questionnaires at two points: once before starting HRT and again after you've started the treatment.

Who can see my answers to the questionnaires?

Your answers will be kept private and handled confidentially by the research team. Your personal details won't be shared.

How to find out more

Valerie Bernard, MD

valerie.bernard@chu-bordeaux.fr -335 56 79 56 79 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.