Skip to main content

Table 1 Number and characteristics of registered Clinical Trials on endometriosis

From: Endometriosis: current challenges in modeling a multifactorial disease of unknown etiology

Clinical Trials Gov Identifier StudyTitle Phase Conditions Interventions Aim Comments Conclusion
NCT01968694 Effects of Intravenous Lidocaine on Endometriosis Pain Not applicable Endometriosis Drug: IV Lidocaine
Drug placebo: IV diphenhydramine
Reduce pain No statistical
analysis
provided
NCT00902746 Efficacy and Safety, Long-Term Study of NPC-01 to Treat Dysmenorrhea Associated With Endometriosis 3 Dysmenorrhea Drug: NPC-01 (Norethisterone and Ethinyl Estradiol) Reduce pain Single Group Assignment (no placebo) No statistical analysis provided
NCT02475564
NCT01620528
NCT01931670
NCT02143713
NCT01760954
Resveratrol for Pain Due to Endometriosis
A Clinical Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain (ELARIS EM-I)
A Global Phase 3 Study to Evaluate the Safety and Efficacy of Elagolix in Subjects With Moderate to Severe Endometriosis-Associated Pain (ELARIS EM-II)
Global Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Women With Moderate to Severe Endometriosis-associated Pain
Study to Evaluate the Long-Term Safety and Efficacy of Elagolix in Adults With Moderate to Severe Endometriosis-Associated Pain
4
3
3
3
3
Endometriosis
Endometriosis
Endometriosis
Endometriosis
Endometriosis
Drug: Placebo
Drug: Resveratrol
Drug: Placebo
Drug: Elagolix
Drug: Placebo
Drug: Elagolix
Drug: Placebo
Drug: Elagolix
Drug: Placebo
Drug: Elagolix
Reduce pain
Safety and efficacy + Reduce pain
Safety and efficacy + Reduce pain
Safety and efficacy + Reduce pain
Safety and efficacy + Reduce pain
Authors conclude that a longer follow-up, for instance 6 months, may impact the results
Participants who completed the 6-month treatment period in the pivotal Study M12-671 (NCT01931670) could enter this extension study
Participants who completed the 6 month treatment period in the pivotal study M12-665 (NCT01620528). The study consists of 2 periods: a 6 month treatment period and a post treatment follow-up period of up to 12 months.
No difference in pain score, CA-125 and prolactin serum levels
The use of Elagolix reduced pain and had adverse effects not yet analyzed by authors
The use of Elagolix reduced pain and had adverse effects not yet analyzed by authors
The use of Elagolix reduced pain and had adverse effects not yet analyzed by authors
The use of Elagolix reduced pain and had adverse effects not yet analyzed by authors
NCT00973973 Efficacy and Safety Study of Elagolix in Women With Endometriosis 2 Endometriosis Drug: Placebo
Drug: Elagolix
Evaluate effects on endometriosis related pelvic pain and its safety All participants still enrolled in the study received 150 mg elagolix once daily The use of Elagolix reduced pain and had adverse effects not yet analyzed by authors
NCT00619866 An Efficacy and Safety Study of Elagolix (NBI-56418) in Women With Endometriosis 2 Endometriosis Drug: Placebo
Drug: Elagolix
Safety and efficacyand to see the effect, if any, on bone mineral density.   Only Elagolix at 8 week treatment had a statistical difference from the placebo group. Adverse effects and bone mineral density were not yet analyzed by authors
NCT00797225 Efficacy and Safety Study of Elagolix Versus Placebo or Leuprorelin Acetate in Endometriosis 2 Endometriosis Drug:Leuprorelin
Drug: Elagolix
Drug: Placebo
Compare drugs safety and beneficial effects of elagolix Leuprorelin is an approved endometriosis therapy Elagolix treatment and Leuprorelin had a statistical difference from the placebo group. Adverse effects and bone mineral density were not yet analyzed by authors
NCT01791413 Effect of Pre-operative Depo Medroxyprogesterone Acetate on Serum Anti-mullerian Hormone Level After Laparoscopic Ovarian Cystectomy of Endometriomas 1 and 2 Endometriosis Drug: Placebo
Drug: depot medroxyprogesterone acetate
Ovarian reserve changes after preoperative medication Ovarian endometrioma No statistical analysis provided
NCT01269125 GnRH-a and Pregnancy Rate in In Vitro Fertilization (IVF) Cycles Not applicable Endometriosis
Infertility
Drug: Leuprolide
Procedure: IVF
Improve the oocyte quality and the fertility  Measured clinical pregnancy rate, embryo quality, fertilization rate, follicular fluid’s TNF-a concentration No difference between groups
NCT01682642 The Influence of Adjuvant Medical Treatment of Peritoneal Endometriosis on the Outcome of IVF. A Prospective Randomized Analysis 4 Infertility
Endometriosis
Drug: Zoladex Impact of treatment prior to IVF on pregnancy rates Number of Metaphase II Cells, Pregnancy Rate, Good Embryo Quality, Number of Pro Nuclear Cell (2PN), Number of Cryopreserved Embryos and Total Follicle Stimulating Hormone (FSH) Dose No statistical analysis
NCT00474851 The Effect of Hormonal Add-Back Therapy in Adolescents Treated With a GnRH Agonist for Endometriosis: A Randomized Trial 2 Endometriosis Drug: Norethindrone acetate + estrogens
Drug: norethindrone acetate + placebo
Maintain skeletal health and quality of life in adolescents Bone Mineral Density, Total Body Bone Mineral Content (BMC), Total Body Bone Mineral Content was higher on the intervention group
NCT01791413 Effect of Pre-operative Depo Medroxyprogesterone Acetate on Serum Anti-mullerian Hormone Level After Laparoscopic Ovarian
Cystectomy of Endometriomas
1 and 2 Endometriosis Drug: depotmedroxyprogesteroneacetate Evaluate ovarian reserve Percentage changes of Serum Anti-Mullerian Hormone (AMH) at 2-week and 3-month post surgery No statistical analysis
NCT01190475 BGS649 Monotherapy in Moderate to Severe Endometriosis Patients 2 Endometriosis Drug: BGS649
Drug: Placebo
Assess the safety and tolerability Proportion of patients who develop 2 or more follicles with diameter 16 mm or larger No statistical analysis
NCT02203331 Bay98-7196, Dose Finding/POC Study 2 Endometriosis Drug: Placebo
Drug: Levonorgestrel
Drug: Anastrozole
Drug: Lupron/Leuprolide acetate
Assess efficacy and safety Different Dose Combinations No difference between groups
NCT01294371 Observational Program to Assess Routine Use of Add-back Therapy in Patients With Endometriosis in Russian Federation, Planned for 6-month Course of Lucrin Depot® (Leuprorelin) Not applicable Genital Endometriosis Non-interventional, observational study Assess rates of administration of add-back therapy in patients with endometriosis   No statistical analysis
  1. All information was taken from US National Library of Medicine, ClinicalTrials.gov without imposing dates or limits