A Study to Assess the Effectiveness and Safety of Different Doses of ASP1707 Compared to Placebo for Endometriosis Associated Pelvic Pain

What Was Tested

The trial (phase 2) is built around Leuprolide for endometriosis.

It had six arms (groups): Placebo (placebo comparator), one (experimental), one (experimental), one (experimental) and one (experimental).

The registry classes the interventions as drug.

Who Took Part

Enrollment: 912 actual participants took part.

It was open to women only aged from 18 years up to 45 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: Pre menopausal female adults with confirmed length and regular menstrual cycle. Surgically diagnosed endometriosis. Moderate to severe endometriosis related pain.

The full record lists 3 inclusion and 9 exclusion criteria; among the exclusions: hormonal contraceptives or other drugs with effects on gynecological endocrinology; surgery for endometriosis within the 4 weeks prior to entry; uterine myoma.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

Random assignment meant chance, not the researchers, decided who got Leuprolide and who got the comparison, which limits bias.

The Leuprolide group and the comparison group ran side by side rather than switching.

Blinding on both sides kept the endometriosis participants and researchers unaware of who received Leuprolide.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2012-12-04 with completion listed for 2015-05-13.

It ran at 85 sites in Japan (34), Poland (9), Ukraine (9), Hungary (7), Bulgaria (6) and Romania (6).

Its stated primary purpose is treatment.

What Was Measured

Researchers chose this as the main measure: Change from baseline to the end of 12 weeks treatment of pain score for overall pelvic pain (time frame: Baseline & Week 12). Change from baseline to the end of 12 weeks treatment of pain score for dysmenorrhea (time frame: Baseline & Week 12). Change from baseline to the end of 12 weeks treatment of pain score for non-menstrual pelvic pain (time frame: Baseline & Week 12).

It also tracked 16 secondary outcomes, for example Change from baseline to the end of 24 weeks treatment of pain score for overall pelvic pain, Change from baseline to the end of 24 weeks treatment of pain score for dysmenorrhea, Change from baseline to the end of 24 weeks treatment of pain score for non-menstrual pelvic pain, Change from baseline to the end of treatment (EoT) of the dyspareunia score, Occurrence of response at the EoT for pain score for overall pelvic pain, dysmenorrhea, non-menstrual pelvic pain and dyspareunia and Change from baseline to the EoT of the mean scores of the modified Biberoglu and Behrman (B&B) symptom and sign domains.

What This Means in Plain Language

Put simply, this is a phase 2, randomized trial of Leuprolide in 912 people with endometriosis.

With 912 participants it is a large trial for this field.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Leuprolide compound page, Endometriosis research.