The effect of cabergoline in infertile women on peritoneal endometriosis related dysmenorrhea, chronic pelvic pain and fertility
Overview
- Phase
- Phase 4
- Status
- Withdrawn
- Sponsor
- Turku University Central Hospital
- Enrollment
- 80
- Locations
- 3
- Primary Endpoint
- The worst Numeric Rating Scale of menstrual pain, weekly pelvic pain and pain during intercourse at baseline, during the treatment, at the end of treatment and at follow up after three natural or ovulation induction cycles and the change of worst NRS at baseline, at the end of treatment and at follow up after three natural or ovulation induction cycles. The number of subjects with reduction of the worst NRS of menstrual pain, weekly pelvic pain and weekly pain during intercourse by ≥30%, ≥50% ja
Overview
Brief Summary
to evaluate the effectiveness of cabergoline on endometriosis associated pain symptoms among infertile patients with mild or moderate endometriosis.
Eligibility Criteria
- Ages
- 18 years to 64 years (18-64 Years)
- Sex
- Female
- Accepts Healthy Volunteers
- No
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 o Adhesions above the level of sacrouterine ligaments demonstrated by absent sliding sign in ultrasound examination or detected surgically o Deep invasive endometriosis of bowel - Hormonal suppression of endometriosis or hormonal contraception within 6 mo - Other diagnosed cause of infertility o Ovulatory dysfunction o Tubal factor (Tubal occlusion, hydrosalpinx, tubal sterilization) o Uterine factor (Submucous myoma, intramural myoma > 4 cm, Uterine malformation apart from Uterus arcuatus) o Male factor o Social 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
Outcomes
Primary Outcomes
The worst Numeric Rating Scale of menstrual pain, weekly pelvic pain and pain during intercourse at baseline, during the treatment, at the end of treatment and at follow up after three natural or ovulation induction cycles and the change of worst NRS at baseline, at the end of treatment and at follow up after three natural or ovulation induction cycles. The number of subjects with reduction of the worst NRS of menstrual pain, weekly pelvic pain and weekly pain during intercourse by ≥30%, ≥50% ja
The worst Numeric Rating Scale of menstrual pain, weekly pelvic pain and pain during intercourse at baseline, during the treatment, at the end of treatment and at follow up after three natural or ovulation induction cycles and the change of worst NRS at baseline, at the end of treatment and at follow up after three natural or ovulation induction cycles. The number of subjects with reduction of the worst NRS of menstrual pain, weekly pelvic pain and weekly pain during intercourse by ≥30%, ≥50% ja
Secondary Outcomes
No secondary outcomes reported
Investigators
Varpu Jokimaa
Scientific
Turku University Central Hospital