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The effect of cabergoline in infertile women on peritoneal endometriosis related dysmenorrhea, chronic pelvic pain and fertility

Phase 1
Conditions
Endometriosis in women with involuntary infertility
MedDRA version: 20.0Level: PTClassification code: 10014778Term: Endometriosis Class: 100000004872
Therapeutic area: Diseases [C] - Female Urogenital Diseases and Pregnancy Complications [C13]
Registration Number
CTIS2022-500792-31-00
Lead Sponsor
Turku University Central Hospital
Brief Summary

Not available

Detailed Description

Not available

Recruitment & Eligibility

Status
ot Recruiting
Sex
Not specified
Target Recruitment
80
Inclusion Criteria

Females -Age 20 – 37 year -Mild or moderate endometriosis either diagnosed by surgery or ultrasound or strong clinical suspicion of peritoneal endometriosis based on NICE Guidelines -Endometriosis related pain NRS > 3 (dysmenorrhea) -Primary or secondary infertility for 1 year or more -Cause of infertility: mild or moderate endometriosis, unknown ‘ -Regular ovulatory cycles

Exclusion Criteria

-Body mass index more than 35 kg/m2 or less than 18 kg/m2 -Severe endometriosis defined as o> 4 cm unilateral endometrioma or bilateral endometriomas oAdhesions above the level of sacrouterine ligaments demonstrated by absent sliding sign in ultrasound examination or detected surgically oDeep invasive endometriosis of bowel -Hormonal suppression of endometriosis or hormonal contraception within 6 mo -Other diagnosed cause of infertility oOvulatory dysfunction oTubal factor (Tubal occlusion, hydrosalpinx, tubal sterilization) oUterine factor (Submucous myoma, intramural myoma > 4 cm, Uterine malformation apart from Uterus arcuatus) oMale factor oSocial infertility -Indication for IVF-treatment -Hyperprolactinemia, macroprolactinemia excluded -Unbalanced hypothyreoidism -Cardiac disorders -Pleural, pericardiac or retroperinoteal fibrosis -Liver dysfunction -Clinical depression or other phychiatric disorder -Previous malignancy -Allergy for cabergoline -Insufficient skills in Finnish, Swedish or English language

Study & Design

Study Type
Interventional clinical trial of medicinal product
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Secondary Outcome Measures
NameTimeMethod
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