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NCT Number: NCT01301885

ENDOMET - Novel Diagnostic Tools and Treatments for Endometriosis

Endometriosis is a chronic disease characterized by the presence of functional endometrial glands and stroma in ectopic locations outside the uterine cavity. The ectopic endometrial tissue responds to estradiol and other hormones similarly to the normal endometrium. Endometriosis is one of the most common benign gynecological conditions, as many as 5-10% of women in the reproductive age may be affected. In addition to pain which may be severe, subfertility is one of the typical problems associated with endometriosis and may be present in up to 40% of those affected. There is lack of a clear correlation between severity of pain and degree of compromised fertility. Different modes of treatment exist. Hormonal treatments are based on the suppression of estrogenic action on endometriosis as well as the endometrium. Unfortunately, discontinuation of the hormonal treatment typically results in a rapid recurrence of the disease. Surgery may alleviate the symptom for different lengths of time, however, curative treatment frequently involves hysterectomy with bilateral oophorectomy. In order to escape this radical treatment, new targeted therapy in the form of novel pharmacological agents would be of crucial importance. Presently, endometriosis can be reliably diagnosed only by laparoscopy. Since this is an invasive surgical procedure, new diagnostic tools would be warmly welcomed. Furthermore, as the progression of the disease is presently impossible to predict, new markers for the "malignancy" of each case are desperately needed.

The aim of the investigators research is to identify expression of endometriosis specific RNAs/proteins. Evaluation of expression profiles in samples of endometriosis and endometrium of patients with careful clinical and surgical classification of endometriosis as well as healthy control women should initially enable to identify novel targets for new therapies and biomarkers. Particularly the different pain symptoms will be recorded annually and evaluated comprehensively. Furthermore, combined with an adequate 10-year follow up (based on a questionnaire, including fertility, received treatments and different pain symptoms; NRS), the study should enable for example to identify markers for endometriosis associated infertility as well as cases where the disease progresses very rapidly or reoccurs. Different forms of effective treatment may thereafter be designed following the identification of such factors.

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Key information

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • study group: surgically and pathologically verified endometriosis
  • control group: existence of endometriosis ruled out in laparoscopy

Exclusion criteria

  • no other significant disease or medication for other diseases
  • suspicion of malignancy
  • pregnancy
  • acute infection
  • insufficient understanding of Finnish language
  • previous hysterectomy and/or bilateral salpingo-oophorectomy

Treatment and study plan

Laparoscopy/Laparotomy

Procedure

Surgical treatment of endometriosis (laparotomy/laparoscopy) or laparoscopic sterilisation. Sample collection in both groups.

Primary outcomes

  1. Intra-tissue steroid profiling indicates differential progesterone and testosterone metabolism in the endometrium and endometriosis lesions.

    Time frame: During the surgical sample collection

  2. Endometrial and endometriotic concentrations of estrone and estradiol are determined by local metabolism rather than circulating levels.

    Time frame: During the surgical sample collection

  3. Serum HE4 concentration differentiates malignant ovarian tumours from ovarian endometriotic cysts.

    Time frame: During the surgical sample collection

  4. A relational database to identify differentially expressed genes in the endometrium and endometriosis lesions

    Time frame: During the surgical sample collection

Secondary outcomes

  1. A prospective 5-year follow-up of pain recurrence after surgical treatment of endometriosis

    Time frame: 5 years (annually) after the completion of patient recruitment

    Questionnaire based evaluation of postoperative pain symptoms

  2. Serum HE-4 concentration is not dependent on menstrual cycle or hormonal treatment among endometriosis patients and healthy premenopausal women

    Time frame: During surgical sample collection

Study contacts

Contact information is provided by the study sponsor or research team.

Antti H Perheentupa, MD PhD

CONTACT

[email protected]

+358-2-3130000 ext. 30222

Kaisa Huhtinen, PhD

CONTACT

[email protected]

+358-2-333 7376

Sponsors and collaborators

Lead sponsor

Turku University Hospital

Other Gov

Collaborators

  • Biotop Oy
  • Drug Discovery Graduate School, Finland
  • Finnish Medical Foundation
  • Hormos Medical
  • PerkinElmer, Wallac Oy
  • Pharmatest Services Ltd
  • The Finnish Funding Agency for Technology and Innovation
  • The National Graduate School of Clinical Investigation, Finland
  • University of Turku
  • VTT Technical Research Centre of Finland

Registry information

Official study title

Novel Diagnostic Tools for Endometriosis and Their Exploitation for Prognosis and Prevention of Complications

Acronym: ENDOMET

Important dates

Study start
2005
Primary completion
2025
Study completion
2028
First posted
Feb 23, 2011
Registry last updated
Aug 16, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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