Study on the Effectiveness and Safety of AMY109 and Desogestrel for Women with Endometriosis

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What is this study about?

This clinical trial is focused on studying the condition known as endometriosis, which affects many women and can cause pain and other symptoms. The study will evaluate the effectiveness and safety of a new treatment called AMY109, which is given as a solution for injection. Additionally, the study will look at the combination of AMY109 with another medication called desogestrel, which is a type of hormone used in some contraceptive pills. The study will also compare these treatments to desogestrel alone.

The purpose of the study is to see how well these treatments work in reducing the severity of endometriosis. Participants will receive one of the treatments or a placebo, which looks like the treatment but does not contain the active medication. The study will involve regular check-ups and assessments, including imaging tests like MRI (Magnetic Resonance Imaging), to monitor changes in the condition. Some participants may also undergo a procedure called laparoscopy, which is a type of surgery that allows doctors to look inside the abdomen to assess the severity of endometriosis.

The study will last for a period of time, during which participants will be closely monitored by healthcare professionals. The goal is to gather information on how the treatments affect the symptoms and progression of endometriosis, providing valuable insights into potential new therapies for this condition. Participants will be required to switch from their usual pain medications to those allowed by the study protocol to ensure accurate results.

1 joining the study

Upon joining the study, eligibility is confirmed based on specific criteria such as age and medical condition. The study focuses on women aged 18 to 49 with moderate to severe endometriosis symptoms.

Participants agree to switch from their usual pain relief medications to those allowed by the study protocol.

2 treatment phase

Participants receive the study medication, AMY109, administered through intravenous infusion. The dosage and frequency are determined by the study protocol.

Some participants may also receive desogestrel, a medication taken orally, in combination with AMY109. The specific dosage and frequency are outlined in the study protocol.

3 monitoring and assessment

Throughout the study, participants undergo regular monitoring to assess the effectiveness and safety of the treatment. This includes medical imaging such as MRI to evaluate changes in endometriosis severity.

Participants may be required to attend scheduled visits for assessments and to report any side effects or changes in symptoms.

4 completion of treatment

At the end of the treatment period, participants undergo final assessments to evaluate the overall impact of the study medication on their condition.

For those in the laparoscopy cohort, a surgical procedure may be performed to further assess the condition post-treatment.

Who Can Join the Study?

Female patients between 18 and 49 years old at the time of giving written consent to participate.
Agree to change from their usual pain relief medications for menstrual pain, pain during intercourse, and non-menstrual pelvic pain to those allowed by the study.
Have moderate to severe endometriosis-related non-menstrual pelvic pain (a pain score of 4 or higher on at least 4 days during the screening period) and menstrual pain (a pain score of 4 or higher on at least 2 days during the screening period).
For the laparoscopy group (only in the UK): Willing to have laparoscopic surgery after the study treatment is completed and understand that the surgery may be delayed due to participation in the study. The doctor should confirm that the patient is suitable for surgical treatment for endometriosis.
For the laparoscopy group (only in the UK): Have had a laparoscopic diagnosis within 9 months before the screening period but have not received any surgical treatment at that time (for example, due to the severity of the disease). This diagnostic laparoscopy should have been done outside of the study following standard practice. Biopsies taken during the laparoscopic diagnosis that are not considered treatments are allowed.
For the laparoscopy group (only in the UK): Have stage II/III endometriosis according to the revised American Society of Reproductive Medicine (r-ASRM) score, based on images from the laparoscopic diagnosis. Videos or notes from the procedure can be used to support the staging if available.
For the imaging group (only in the EU): Have a clinical diagnosis of endometriosis based on at least one of the following: Laparoscopy or laparotomy performed within 10 years before giving written consent, or clinical symptoms and imaging assessment (like TVUS or MRI) before starting the treatment period. Must have at least one ovarian endometrioma on MRI assessed by a central reader during the screening period.
For the imaging group (only in the EU): Have at least one endometriotic nodule with a short diameter greater than 5mm and a long diameter greater than 10mm using MRI assessed by a central reader during the screening period. Patients with a nodule that cannot be distinguished from adenomyosis can participate if another endometriotic nodule or endometrioma is identified during the screening period.

Who Cannot Join the Study?

Patients who are not women cannot participate in the study.
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 requirements.
Patients who are considered part of a vulnerable population may not be eligible. A vulnerable population includes groups that might be at a higher risk of harm or exploitation.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Gyncentrum Sp. z o.o.	Katowice	Poland
Niepubliczny Zaklad Opieki Zdrowotnej Medem Wilk Sp. j.	Katowice	Poland

Other Sites

Site Name	City	Country
Twoja Przychodnia Szczecinskie Centrum Medyczne Sp. z o.o.	Szczecin	Poland
Centrul Medical Unirea S.R.L.	Brasov	Romania
Clinical Medical Research Sp. z o.o.	Katowice	Poland
Fakultni Nemocnice Brno	Brno	Czechia
Mrepkzf Coqi Sjskxb	Timisoara	Romania
Hal Sah z ognh	Lublin	Poland
Sbscxhwnseuiarj Pcldvene Gtpbehuisbpxjp Jqnfop Tozqtdozpjc shkyr	Bialystok	Poland

Trial status

Country	Status	Recruitment Start
Czechia	Not recruiting	01.08.2024
Poland	Not recruiting	01.08.2024
Romania	Not recruiting	01.08.2024

Trial locations

Investigated drugs:

AMY109 is an investigational medication being studied for its potential to help women with endometriosis. Endometriosis is a condition where tissue similar to the lining inside the uterus grows outside of it, causing pain and other symptoms. This medication is being tested to see if it can reduce the severity of the disease as observed through medical imaging techniques.

Desogestrel is a type of hormonal medication commonly used in birth control pills. In this study, it is being used to see how effective it is in managing the symptoms of endometriosis. Desogestrel works by altering hormone levels in the body, which can help reduce the growth of endometrial tissue and alleviate pain.

Investigated diseases:

Endometriosis

Endometriosis – Endometriosis is a condition where tissue similar to the lining inside the uterus 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 widely among those affected.

Trial ID:

2023-507289-14-00

Protocol code:

AMY106EU

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effectiveness and Safety of AMY109 and Desogestrel for Women with Endometriosis

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?