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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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3 April 2023 |
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Main ID: |
NCT02197923 |
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Date of registration:
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17/07/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Norwegian Adenomyosis Study II: Gene Expression Profiling of Adenomyosis
NAPPED II |
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Scientific title:
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Norwegian Adenomyosis Study: Pathophysiology, Peristalsis, Expression Profiling and Diagnosis, Part 2 |
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Date of first enrolment:
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August 6, 2014 |
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Target sample size:
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80 |
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Recruitment status: |
Active, not recruiting |
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URL:
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https://clinicaltrials.gov/show/NCT02197923 |
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Study type:
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Observational |
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Study design:
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Phase:
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Countries of recruitment
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Norway
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Contacts
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Name:
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Tina Tellum, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Oslo University Hospital |
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Name:
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Erik Qvigstad, PhD, MD |
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Address:
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Telephone:
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Email:
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Affiliation:
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Oslo University Hospital, Ullevål |
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Key inclusion & exclusion criteria
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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
Age minimum:
30 Years
Age maximum:
50 Years
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Adenomyosis
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Intervention(s)
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Procedure: endometrial biopsy
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Procedure: Myometrial biopsy
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Primary Outcome(s)
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Sensitivity and specificity of biopsies for adenomyotic tissue in percent (%)
[Time Frame: At time of hysterectomy]
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Secondary Outcome(s)
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difference hormone serum-levels in fold
[Time Frame: at time of hysterectomy]
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multiple comparison of gene expression, measured in fold
[Time Frame: at time of biopsy taking]
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Serum level of ER, in nmol/L
[Time Frame: at time of hysterectomy]
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Serum levels of FSH in U/L
[Time Frame: at time of hysterectomy]
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Serum levels of prolactin in mU/L
[Time Frame: at time of hysterectomy]
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Serum levels of AMH in pmol/L
[Time Frame: at time of hysterectomy]
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Frequency of complications related to biopsy taking in percent (%)
[Time Frame: through 1 hour after biopsytaking]
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Serum levels of LH in U/L
[Time Frame: at time of hysterectomy]
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Secondary ID(s)
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2014/637b
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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