Table 1 Number and characteristics of registered Clinical Trials on endometriosis

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