Norwegian Adenomyosis Study I
CompletedNCT02201719
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This study has no listed site in Canada in this snapshot. It is included as part of the worldwide chronic pain corpus.
Brief summary (from the registry)
Adenomyosis is characterized by the appearance of endometrial cells in the muscular layer of the uterus. It affects about 15-20% of the female population. The symptoms of adenomyosis are heavy menstrual bleedings and painful menstruation (dysmenorrhea) and in addition chronic pelvic pain. Subfertility and infertility have been correlated with adenomyosis. Parity, age and uterine abrasion increase the risk of adenomyosis. Hormonal factors such as local hyperestrogenism and elevated levels of prolactin have been identified, but autoimmune and mechanical factors are also hypothesized. Regarding treatment, the most effective measure is hysterectomy. As this is a very drastic measure in younger women, levonogestrel-releasing intrauterine devices, Gonadotropin releasing hormone (GnRH)-analogues, Danazol, uterine embolization and endometrial ablation have been tried, but studies are few in number, retrospective, and have small sample sizes. Adenomyosis has so far not been subject to extensive research efforts. The pathogenesis of adenomyosis remains still unclear, there are not many satisfying treatment options and diagnostics include mostly magnetic resonance imaging (MRI) and histology. The investigators designed a series of 3 studies with a broad approach in understanding adenomyosis. This is part 1. NAPPED-1: comparison of 3D-transvaginal ultrasound with MRI and histology in the diagnostic of adenomyosis
Study details
- Official title
- Norwegian Adenomyosis Study: Pathophysiology, Peristalsis, Expression Profiling and Diagnostics, Part I
- Conditions
- Adenomyosis
- Sponsor
- Oslo University Hospital
- Collaborators
- Helse Sor-Ost
- Start date
- 2014-07
- Primary completion
- 2017-01
- Sex
- Female
- Age range
- from 25 Years to 50 Years
- Healthy volunteers
- true
- Results posted
- No results posted in this snapshot
- Countries
- Norway
- Total sites listed
- 1
Eligibility criteria
Show eligibility criteria (verbatim from the registry)
Inclusion Criteria: * Premenopausal women aged 30 - 50 years old * scheduled for vaginal, abdominal or laparoscopic total hysterectomy * one or more of the following clinical symptoms: bleeding disorders (menorrhagia, irregular bleeding, hypermenorrhoea), chronic pelvic pain, dysmenorrhoea, or dyspareunia * junction zone definable Exclusion Criteria: * postmenopausal women, * pregnancy * gynecological cancer * GnRH analog therapy or systemic hormone therapy in the last three months prior to hysterectomy * junctional zone not identifiable
Source: ClinicalTrials.gov (US National Library of Medicine), snapshot October 2026. Check the registry for current recruiting status. Record: https://clinicaltrials.gov/study/NCT02201719