The effect of cabergoline in infertile women on peritoneal endometriosis related dysmenorrhea, chronic pelvic pain and fertility
试验速览
- 阶段
- 4 期
- 状态
- 撤回
- 发起方
- 入组人数
- 80
- 试验地点
- 3
- 主要终点
- 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
研究概览
简要总结
to evaluate the effectiveness of cabergoline on endometriosis associated pain symptoms among infertile patients with mild or moderate endometriosis.
入排标准
- 年龄范围
- 18 years 至 64 years（18-64 Years）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
结局指标
主要结局
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
次要结局
未报告次要终点
研究者
Varpu Jokimaa
Scientific
Turku University Central Hospital