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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. Identifier: NCT01631981
Recruitment Status : Completed
First Posted : June 29, 2012
Last Update Posted : June 3, 2014
Information provided by (Responsible Party):
PregLem SA

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.

Condition or disease Intervention/treatment Phase
Endometriosis Drug: PGL2001 + Primolut-Nor 5 Drug: Placebo + Primolut-Nor 5 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 162 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Endometriosis

Arm Intervention/treatment
Experimental: PGL2001
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.

Primary Outcome Measures :
  1. Non-menstrual pelvic pain. [ Time Frame: Daily collection up to 16 weeks ]
    Use of a Visual Analogue Scale (VAS).

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

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 identifier (NCT number): NCT01631981

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Sponsors and Collaborators
PregLem SA
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Responsible Party: PregLem SA Identifier: NCT01631981    
Other Study ID Numbers: PGL11-007
First Posted: June 29, 2012    Key Record Dates
Last Update Posted: June 3, 2014
Last Verified: June 2014
Additional relevant MeSH terms:
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