PGL2001 Proof of Concept Study in Symptomatic Endometriosis (AMBER)
|ClinicalTrials.gov Identifier: NCT01631981|
Recruitment Status : Completed
First Posted : June 29, 2012
Last Update Posted : June 3, 2014
|Condition or disease||Intervention/treatment||Phase|
|Endometriosis||Drug: PGL2001 + Primolut-Nor 5 Drug: Placebo + Primolut-Nor 5||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||162 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)|
|Official Title:||A Phase II, Multicentre, Randomised, Two-Arm, Parallel Group, Double-Blind, Placebo Controlled Study of the Steroid Sulfatase Inhibitor PGL2001 With Concomitant Administration of NETA (Norethisterone Acetate) for the Treatment of Symptoms Related to Endometriosis|
|Study Start Date :||June 2012|
|Actual Primary Completion Date :||October 2013|
|Actual Study Completion Date :||May 2014|
PGL2001 + NETA followed by NETA-only follow-up period
Drug: PGL2001 + Primolut-Nor 5
PGL2001(estradiol sulfamate, E2MATE, ZK190628), Tablets, 1mg. 4 mg weekly for 4 weeks followed by 2mg weekly for 12 weeks.
Norethisterone acetate (NETA), Tablets, 5mg. Once daily for 16 weeks plus during follow-up.
Placebo Comparator: Placebo
Placebo + NETA followed by NETA-only follow-up period
Drug: Placebo + Primolut-Nor 5
Placebo, Tablets.4 tablets weekly for 4 weeks followed by 2 tablets weekly for 12 weeks.
Norethisterone acetate (NETA), Tablets, 5mg.Once daily for 16 weeks plus during follow-up.
- Non-menstrual pelvic pain. [ Time Frame: Daily collection up to 16 weeks ]Use of a Visual Analogue Scale (VAS).
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01631981