Study on Cabergoline for Pain and Fertility in Women with Endometriosis and Infertility

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What is this study about?

This clinical trial is focused on studying the effects of the medication cabergoline on women who are experiencing endometriosis and are facing challenges with infertility. Endometriosis is a condition where tissue similar to the lining inside the uterus grows outside of it, often causing pain and fertility issues. The study aims to understand how cabergoline can help reduce pain associated with endometriosis, such as menstrual pain, chronic pelvic pain, and pain during intercourse, and to see if it can improve fertility in women with mild to moderate endometriosis.

Participants in the study will receive either cabergoline or a placebo. Cabergoline is a medication that works by affecting the levels of certain chemicals in the brain, which can help manage symptoms of endometriosis. The study will observe the participants over a period of time to assess changes in their pain levels and fertility status. The goal is to determine if cabergoline can significantly reduce pain and improve the chances of conception in women with endometriosis.

Throughout the study, participants will be monitored to track their pain levels and any changes in their fertility. The study will also evaluate the overall impact of cabergoline on the quality of life for women dealing with endometriosis-related symptoms. This research is important for finding new ways to help women manage the symptoms of endometriosis and improve their chances of becoming pregnant.

1 joining the study

Upon joining the study, you will be informed about the purpose and procedures of the clinical trial. This study aims to evaluate the effectiveness of cabergoline on pain symptoms associated with endometriosis in women experiencing infertility.

2 initial assessment

An initial assessment will be conducted to confirm eligibility. This includes verifying that you are a female aged 20 to 37 years with mild or moderate endometriosis, experiencing pain related to endometriosis, and have been infertile for one year or more.

3 treatment phase

During the treatment phase, you will be administered Dostinex 0.5 mg tablets. The medication is taken orally. The dosage and frequency will be specified by the study team, and you will be required to follow the instructions carefully.

4 monitoring and follow-up

Throughout the trial, your symptoms will be monitored. This includes assessing the severity of menstrual pain, weekly pelvic pain, and pain during intercourse using a Numeric Rating Scale (NRS).

At the end of the treatment, and after three natural or ovulation induction cycles, follow-up assessments will be conducted to evaluate any changes in your symptoms.

5 completion of the trial

Upon completion of the trial, the study team will review the data collected to determine the effectiveness of the treatment. You will be informed about the results and any further steps if necessary.

Who Can Join the Study?

Must be a female.
Age between 20 and 37 years.
Have mild or moderate endometriosis, which is a condition where tissue similar to the lining inside the uterus grows outside of it. This must be diagnosed by surgery, ultrasound, or a strong clinical suspicion based on guidelines.
Experience endometriosis-related pain with a pain score greater than 3 on a scale called NRS, specifically for menstrual pain (dysmenorrhea).
Have been experiencing primary or secondary infertility for 1 year or more. Primary infertility means never having been pregnant, while secondary infertility means having difficulty getting pregnant after already having a child.
The cause of infertility should be mild or moderate endometriosis or unknown.
Have regular ovulatory cycles, meaning regular menstrual cycles where ovulation occurs.

Who Cannot Join the Study?

Patients who are not women cannot participate.
Patients who are not experiencing endometriosis cannot participate. Endometriosis is a condition where tissue similar to the lining inside the uterus grows outside the uterus, causing pain and sometimes infertility.
Patients who do not have infertility cannot participate. Infertility means having difficulty getting pregnant.
Patients with severe endometriosis cannot participate. Only those with mild or moderate endometriosis are eligible.
Patients who are not within the specified age range cannot participate. The age range is not specified here, but it is important to check if you meet the age criteria.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

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Other Sites

Site Name	City	Country
Tampere University Hospital	Tampere	Finland
Oulu University Hospital	Oulu	Finland
Central Finland Hospital District Central Finland Hospital Nova	Jyvaskyla	Finland

Trial status

Country	Status	Recruitment Start
Finland	Not yet recruiting	02.01.2023

Trial locations

Investigated drugs:

Cabergoline

Cabergoline is a medication used in this clinical trial to help manage pain and improve fertility in women with endometriosis. Endometriosis is a condition where tissue similar to the lining inside the uterus grows outside of it, causing pain and sometimes infertility. Cabergoline works by reducing the levels of a hormone called prolactin in the body, which can help decrease the growth of endometrial tissue and alleviate pain. This medication is being tested to see if it can effectively reduce pain symptoms associated with endometriosis and improve the chances of becoming pregnant for women who are experiencing infertility due to this condition.

Investigated diseases:

Endometriosis

Endometriosis – Endometriosis is a condition where tissue similar to the lining inside the uterus, called endometrium, starts to grow outside the uterus. This tissue can be found on the ovaries, fallopian tubes, and the outer surface of the uterus, as well as other organs in the pelvis. The misplaced tissue continues to act as it normally would, thickening, breaking down, and bleeding with each menstrual cycle. However, because this tissue has no way to exit the body, it becomes trapped, leading to inflammation and the formation of scar tissue. Over time, this can cause pain, especially during menstruation, and may lead to fertility problems. The severity of symptoms can vary, with some women experiencing mild discomfort and others suffering from severe pain.

Trial ID:

2022-500792-31-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Cabergoline for Pain and Fertility in Women with Endometriosis and Infertility

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?