Table 1 A table showing the various completed clinical trials for conventional therapy in endometriosis
Phase | Study design | No of participants | Eligibility criteria | Arms of the study | Study findings | Inference | Study |
|---|---|---|---|---|---|---|---|
Phase IV | A randomized, parallel, open-label study to determine whether endometrial implantation markers predict embryo transfer fertilization outcomes in vitro in subjects already administered leuprolide acetate | 37 participants | Infertility patients, diagnosis of endometriosis patients, patients who have regular menses, normal ovarian reserve testing | Intervention: Leuprolide acetate in depot suspension 3.75Â mg intramuscular every 28Â days | The study found that there were no significant differences for outcomes such as rate of fertilization, stimulation of gonadotrophin hormones, etc. A high rate of fertilization rates was observed in the group of patients who were administered GnRH regimen which led to a larger frequency of implantations within them | It was concluded from this study that GnRH agonist administration in endometriosis can lead to an increase in the rates of pregnancies in comparison to the conventional ovarian stimulation techniques | Surrey et al. [58] |
Phase II | A randomized parallel-assignment study to observe the efficacy of hormonal therapy in combination with GnRH agonist in patients suffering from endometriosis | 53 participants | Women aged 13–22 years, body weight between 18 and 30 kg/m2, surgical diagnosis of endometriosis, willing to comply with study requirements | Intervention: Norethindrone acetate 5 mg orally + Conjugated equine estrogens 0.625 mg orally Control: Norethindrone acetate 5 mg + placebo capsule 1 pill daily | At 12 months, the intervention group increased the bone mineral density (BMD) and the overall mineral content of the body, while the control group did not show these outcomes. Quality-of-life assessments showed greater improvements in physical functioning with the interventional group. There were no significant adverse events were reported | Add-back therapy with norethindrone acetate led to preservation of the skeletal health in endometriosis patients, the combination of norethindrone acetate and conjugated equine estrogens being led to higher elevations in the BMD of the body. The therapy was safe and effective, with no tolerability issues | DiVasta et al. [59] |
Phase II | A randomized, parallel-assignment pilot study to determine the effect of dopamine receptor agonist therapy for pain relief in women suffering from endometriosis | 10 participants | Women with confirmed case of endometriosis, age between 15 and 40Â years | Intervention 1: Cabergoline (0.5Â mg PO two times a week for 6Â months duration) Intervention 2: Norethindrone acetate (5Â mg po daily for 6Â months) | It was observed from this study that many subjects taking cabergoline experienced a decrease in pain scores and improvement in pain complaints compared to subjects treated with Norethindrone acetate. Cabergoline was also well tolerated by the patients | It was concluded that Cabergoline could be a safe and effective therapeutic alternative for chronic pain in endometriosis resistant to standard care, according to a pilot study. Larger randomized trials are needed to confirm these findings | DiVasta et al. [60] |
Phase not applicable | A prospective, randomized, parallel-assignment clinical trial to study the effect of administration of GnRH agonist before in vitro fertilization to observe fertilization rate and pregnancy rate in endometriosis patients | 180 participants | Patients with infertility, endometriosis stage 1 | Intervention: Leuprolide (single injection of 3.75Â mg every 28Â days) Procedure: In vitro fertilization (IVF) | The use of GnRH agonist resulted in a decrease in Follicular fluid cytokines in women compared to those who did not receive this regimen. However, no significant improvement took place in terms of embryo quality, rate of implantation, or rate of pregnancy | Low follicular fluid cytokine levels along with high rates of implantations were noticed in subjects receiving GnRH agonist for the duration of 3Â months, with no significant difference in pregnancy and implantation rate | Kaponis et al. [61] |