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PGL2001 Proof of Concept Study in Symptomatic Endometriosis (AMBER)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01631981
Recruitment Status : Completed
First Posted : June 29, 2012
Last Update Posted : June 3, 2014
Sponsor:
Information provided by (Responsible Party):
PregLem SA

Tracking Information
First Submitted Date  ICMJE June 19, 2012
First Posted Date  ICMJE June 29, 2012
Last Update Posted Date June 3, 2014
Study Start Date  ICMJE June 2012
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 28, 2012)
Non-menstrual pelvic pain. [ Time Frame: Daily collection up to 16 weeks ]
Use of a Visual Analogue Scale (VAS).
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PGL2001 Proof of Concept Study in Symptomatic Endometriosis
Official Title  ICMJE 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
Brief Summary This is a Phase II, multicentre, randomised, two-arm, parallel group ,double-blind, placebo controlled, study to investigate the efficacy, safety, pharmacokinetics and pharmacodynamics of the steroid sulfatase inhibitor PGL2001 with concomitant, continuous NETA administration for the treatment of pain symptoms suggestive of endometriosis. The target population will be women of reproductive age with symptoms suggestive of endometriosis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Endometriosis
Intervention  ICMJE
  • 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.

  • 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.

Study Arms  ICMJE
  • Experimental: PGL2001
    PGL2001 + NETA followed by NETA-only follow-up period
    Intervention: Drug: PGL2001 + Primolut-Nor 5
  • Placebo Comparator: Placebo
    Placebo + NETA followed by NETA-only follow-up period
    Intervention: Drug: Placebo + Primolut-Nor 5
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 2, 2014)
162
Original Estimated Enrollment  ICMJE
 (submitted: June 28, 2012)
132
Actual Study Completion Date  ICMJE May 2014
Actual Primary Completion Date October 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Provide written informed consent prior to initiation of any study related procedures.
  • Be a woman of reproductive age between 18 and 45 years inclusive.
  • Present with clinical signs suggestive of endometriosis.
  • Be suffering from non menstrual pelvic pain and dysmenorrhea suggestive of endometriosis for at least 3 months prior to screening visit.

Exclusion Criteria:

  • Be pregnant or currently lactating.
  • Have diseases or suspected diseases which may cause pelvic pain not due to endometriosis.
  • Have had any surgical treatment for endometriosis within the last 12 months.
  • Have documented significant adenomyosis.
  • Have participated in another clinical trial within the 30 days prior to the screening visit.
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Hungary,   Poland,   Romania
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01631981
Other Study ID Numbers  ICMJE PGL11-007
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party PregLem SA
Study Sponsor  ICMJE PregLem SA
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account PregLem SA
Verification Date June 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP