AdenomyosisNAPPED INCT02201719
Norwegian Adenomyosis Study I
An observational study of Adenomyosis, run by Oslo University Hospital at 1 site in Norway.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 25 to 50 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Adenomyosis
- How many people
- 100 participants
- Where
- 1 siteNorway
- Study dates
- Jul 2014to Jan 2017
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 to 50 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Women referred to our clinic and volunteering to participate and that are registrated in Norway with a norwegian social security number.
Who may be able to join
- 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
Who cannot join
- postmenopausal women,
- pregnancy
- gynecological cancer
- GnRH analog therapy or systemic hormone therapy in the last three months prior to hysterectomy
- junctional zone not identifiable
Trial locations and contacts
1 site in 1 country.
Norway1 site
Department of Gynecology, Oslo University Hospital Ullevål
Oslo, Oslo, 0382
About this study
Official title: Norwegian Adenomyosis Study: Pathophysiology, Peristalsis, Expression Profiling and Diagnostics, Part I
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.
Read more
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
Read the detailed description
Diagnosis of Adenomyosis with 3D and 2D transvaginal ultrasound. Prospective study of a consecutive series of 101 patients that are scheduled for hysterectomy and suffer from bleeding disorders, chronic pelvic pain, dysmenorrhea or dyspareunia. All patients will undergo transvaginal 2D- ultrasound, 3D-ultrasound and power doppler (PD)-ultrasound (TVU), magnetic resonance imaging of the pelvic organs (MRI) and hysterectomy.
We will investigate the specificity and sensitivity of 3D and 2D transvaginal ultrasound in the diagnosis of adenomyosis and compare data with MRI and histopathology, which is the gold standard by today. In addition, we will collect anamnestic information that might point to risk factors or connections to prior obstetrical complications and medicine use. In our study the pathologist will not be blinded to our ultrasound findings, and we want to investigate if this will raise the sensitivity of histology findings of adenomyosis.
- Conditions
- Adenomyosis
- Keywords
- Adenomyosis, Dysmenorrhea, Chronic pelvic pain, Infertility, Sensitivity histology, womens health, junction zone
- Medical subject headings
- Adenomyosis, Dysmenorrhea, Infertility
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Hysterectomy Adenomyosis | Adenomyosis present | |
| Hysterectomy no adenomyosis | Adenomyosis not present |
What is being measured
The primary outcome is the main question the study is designed to answer.
Difference in sensitivity and specificity of 3D TVU and MRI; in percentage points (%)
Sensitivity and specificity of 3D TVU in the diagnosis of adenomyosis compared to MRI.
Measured: within 4 weeks after 3D TVU
Secondary outcomes (8)
Positive and negative predictive value of 3D TVU in percent (%)
Positive and negative predictive value of 3D TVU in diagnosis of adenomyosis. The histological examination is the end-point because it is still regarded to be the gold-standard in diagnosis of adenomyosis.
Measured: within 17 weeks after 3D TVU
Difference in sensitivity and specificity of 3D TVU and 2D TVU; in percentage points (%)
The sensitivity and specificity of 3D TVU in the diagnosis of adenomyosis will also be compared to 2D TVU, in addition to MRI (see primary outcome measure).
Measured: within 17 weeks after 3D TVU
Difference in max. thickness of junction zone, in millimeters (mm)
Compares measurements of junction zone made by 3D TVU and MRI.
Measured: post ovulatory in any menstruational cycle prior to surgery, within 4 weeks after 3D TVU
Prevalence of sub- and infertility, percent (%)
Questionnaire-based investigation. Prevalence of sub- and infertility in their medical history of the study population.
Measured: at time of enrollment
Difference in sensitivity and specificity of 3D TVU and histopathology; in percentage points (%)
The sensitivity and specificity of 3D TVU in the diagnosis of adenomyosis will also be compared to 2D TVU, in addition to MRI (see primary outcome measure) and histopathology, which is still the gold standard.
Measured: within 17 weeks after 3D TVU
Prevalence of miscarriages, in percent (%)
Questionnaire-based investigation. Prevalence of miscarriages in the medical history of the study population.
Measured: at time of enrollment
Prevalence of previous gynecological surgeries, in percent (%)
Questionnaire-based investigation. Prevalence of previous gynecological surgical interventions in the medical history of the study population.
Measured: at time of enrollment
Prevalence of previous obstetrical complications, in percent (%)
Questionnaire-based investigation. Prevalence of previous obstetrical complications in the medical history of the study population.
Measured: menarche to time of enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2014 (estimated)
- Study startJul 2014
- Primary completionJan 2017
- Study completionJan 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AdenomyosisStudies of the same condition, open and under way.
- More trials run by Oslo University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Oslo University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Helse Sor-Ost
- Responsible party
- Principal investigator, Tina Tellum, Oslo University Hospital
- Investigators
- Marit Lieng, PhD, MD, Principal investigator, Oslo University Hospital, Ullevål
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02201719
- Sponsor's protocol ID
- 2014/637a
- Acronym
- NAPPED I
- Status last verified
- Apr 2017
- First submitted
- 2 Jul 2014
- Last updated
- 5 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Tellum T, Nygaard S, Skovholt EK, Qvigstad E, Lieng M. Development of a clinical prediction model for diagnosing adenomyosis. Fertil Steril. 2018 Oct;110(5):957-964.e3. doi: 10.1016/j.fertnstert.2018.06.009.
PubMed 30316443
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Norwegian Adenomyosis Study: Pathophysiology, Peristalsis, Expression Profiling and Diagnostics, Part I
- ClinicalTrials.gov ID
- NCT02201719
- Acronym / sponsor ID
- NAPPED I / 2014/637a
- Conditions
- Adenomyosis
- Keywords
- Adenomyosis, Dysmenorrhea, Chronic pelvic pain, Infertility, Sensitivity histology, womens health, junction zone
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Oslo University HospitalUniversity, hospital or other
- Collaborators
- Helse Sor-Ost
- Study start
- Jul 2014
- Primary completion
- Jan 2017 (actual)
- Study completion
- Jan 2017 (actual)
- First posted
- 28 Jul 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Detailed description
Diagnosis of Adenomyosis with 3D and 2D transvaginal ultrasound. Prospective study of a consecutive series of 101 patients that are scheduled for hysterectomy and suffer from bleeding disorders, chronic pelvic pain, dysmenorrhea or dyspareunia. All patients will undergo transvaginal 2D- ultrasound, 3D-ultrasound and power doppler (PD)-ultrasound (TVU), magnetic resonance imaging of the pelvic organs (MRI) and hysterectomy.
We will investigate the specificity and sensitivity of 3D and 2D transvaginal ultrasound in the diagnosis of adenomyosis and compare data with MRI and histopathology, which is the gold standard by today. In addition, we will collect anamnestic information that might point to risk factors or connections to prior obstetrical complications and medicine use. In our study the pathologist will not be blinded to our ultrasound findings, and we want to investigate if this will raise the sensitivity of histology findings of adenomyosis.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Hysterectomy Adenomyosis | – | –Adenomyosis present |
| Hysterectomy no adenomyosis | – | –Adenomyosis not present |
Who may qualify
- Ages
- 25 to 50 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Women referred to our clinic and volunteering to participate and that are registrated in Norway with a norwegian social security number.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- postmenopausal women,
- pregnancy
- gynecological cancer
- GnRH analog therapy or systemic hormone therapy in the last three months prior to hysterectomy
- junctional zone not identifiable
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Difference in sensitivity and specificity of 3D TVU and MRI; in percentage points (%)
Time frame: within 4 weeks after 3D TVU
Sensitivity and specificity of 3D TVU in the diagnosis of adenomyosis compared to MRI.
8 secondary outcomes
Positive and negative predictive value of 3D TVU in percent (%)
Time frame: within 17 weeks after 3D TVU
Difference in sensitivity and specificity of 3D TVU and 2D TVU; in percentage points (%)
Time frame: within 17 weeks after 3D TVU
Difference in max. thickness of junction zone, in millimeters (mm)
Time frame: post ovulatory in any menstruational cycle prior to surgery, within 4 weeks after 3D TVU
Prevalence of sub- and infertility, percent (%)
Time frame: at time of enrollment
Difference in sensitivity and specificity of 3D TVU and histopathology; in percentage points (%)
Time frame: within 17 weeks after 3D TVU
Prevalence of miscarriages, in percent (%)
Time frame: at time of enrollment
Prevalence of previous gynecological surgeries, in percent (%)
Time frame: at time of enrollment
Prevalence of previous obstetrical complications, in percent (%)
Time frame: menarche to time of enrollment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2017.
- Derived from this study: PubMed 30316443Tellum T, Nygaard S, Skovholt EK, Qvigstad E, Lieng M. Development of a clinical prediction model for diagnosing adenomyosis. Fertil Steril. 2018 Oct;110(5):957-964.e3. doi: 10.1016/j.fertnstert.2018.06.009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marit Lieng, PhD, MD principal investigator
Oslo University Hospital, Ullevål
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Adenomyosis, run by Oslo University Hospital at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 5 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference in sensitivity and specificity of 3D TVU and MRI; in percentage points (%) (time frame: within 4 weeks after 3D TVU). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02201719, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Apr 2017.