Randomized Trial Assessing Quinagolide Vaginal Ring for Endometriosis-related Pain

(RAQUEL Trial)

Recruiting at 42 trial locations

Overseen By Global Clinical Compliance

Age: 18+

Sex: Female

Trial Phase: Phase 2

Sponsor: Ferring Pharmaceuticals

Disqualifiers: Bone diseases, Heart abnormalities, Mental illness, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 16 weeks

22 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify if you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the drug Quinagolide?

The research on pergolide, a drug similar to Quinagolide, shows that it can be effective in treating Parkinson's disease, especially in patients who no longer respond to other treatments. Studies found that pergolide improved symptoms and reduced disability in patients, suggesting that Quinagolide might also be effective in similar conditions. ^{1 2 3 4 5}

Is Quinagolide generally safe for humans?

The safety of Quinagolide, like other drugs, is monitored through databases that track adverse drug reactions (ADRs). These databases help identify significant effects by comparing the number of ADR reports to the amount of the drug distributed. While specific safety data for Quinagolide isn't detailed here, such systems are in place to ensure ongoing safety monitoring. ^{6 7 8 9 10}

What is the purpose of this trial?

This trial is testing a vaginal ring that releases a medication called quinagolide to help reduce pain in women with moderate to severe endometriosis. The goal is to see if this treatment is effective.

Research Team

Global Clinical Compliance

Principal Investigator

Ferring Pharmaceuticals

Eligibility Criteria

Inclusion Criteria

Body mass index (BMI) of 18-42 kg/m2 (both inclusive) at screening.

Initial confirmation of endometriosis by laparoscopy or laparotomy within the last 10 years before the run-in visit or visualization of persistent endometrioma by repeat ultrasound.

Transvaginal ultrasound documenting a uterus with no clinically significant abnormalities and presence of at least one ovary with no clinically significant abnormalities (with the exception of endometrioma) at the run-in visit.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive quinagolide or placebo via an extended-release vaginal ring for 4 menstrual cycles

16 weeks

Monthly visits for ring replacement and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Quinagolide

Participant Groups

Group I: Quinagolide 720 µg Experimental Treatment 1 Intervention

Vaginal ring containing Quinagolide 720 μg, with daily target release rate of 9 μg

Group II: Quinagolide 360 µg Experimental Treatment 1 Intervention

Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg

Group III: Quinagolide 1080 µg Experimental Treatment 1 Intervention

Vaginal ring containing Quinagolide 1080 μg, with daily target release rate of 13.5 μg

Group IV: Placebo Placebo Group 1 Intervention

Vaginal ring containing matching placebo

Who Is Running the Clinical Trial?

Ferring Pharmaceuticals

Lead Sponsor

Trials

323

Recruited

1,242,000+

Pierre-Yves Berclaz

Ferring Pharmaceuticals

Chief Medical Officer since 2023

MD from the University of Lausanne, PhD in Molecular Biology from the Cincinnati College of Medicine

Jean-Frédéric Paulsen

Ferring Pharmaceuticals

Chief Executive Officer since 2023

Master’s degree in Finance from the London School of Economics and Political Science

Findings from Research

In an open trial involving 23 patients with idiopathic Parkinson's disease who had previously experienced loss of efficacy or side effects from other treatments, pergolide mesylate showed improvement in parkinsonian symptoms that lasted for 6 months.

All patients experiencing the on-off phenomenon, a common issue in Parkinson's treatment, reported relief from their symptoms while on pergolide, and no significant side effects were observed, indicating its safety and efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pergolide mesylate and idiopathic Parkinson disease. Tanner, CM., Goetz, CG., Glantz, RH., et al.[2019]

The safety of marketed drugs is a significant concern, as some commonly prescribed medications can lead to serious or life-threatening side effects in patients.

The ChEMBL resource will provide a curated drug safety data set, including toxicity classifications and black box warnings, which will be freely available and regularly updated to aid in drug safety research and discovery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Drug Safety Data Curation and Modeling in ChEMBL: Boxed Warnings and Withdrawn Drugs. Hunter, FMI., Bento, AP., Bosc, N., et al.[2023]

The study found that there is no formal definition of 'adversity' or guidance on determining the No Observed Adverse Effect Level (NOAEL) in safety pharmacology, indicating a lack of standardized practices in this area.

It was concluded that using NOAEL in safety pharmacology is not recommended, as the diverse functional endpoints measured do not fit into a simple toxic/non-toxic classification, suggesting a need for more nuanced risk assessments in drug development.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Is there a role for the no observed adverse effect level in safety pharmacology? Mow, T., Andersen, NK., Dragsted, N., et al.[2021]

The study reviews drug-induced ocular side effects, categorizing them based on certainty and clinical importance, which helps in recognizing and managing these adverse reactions effectively.

It emphasizes the importance of pharmacovigilance in ocular toxicology, ensuring that healthcare professionals are aware of potential ocular side effects from medications and can report and treat them appropriately.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Ocular adverse drug reactions. Fraunfelder, FW.[2019]

References

1. England pubmed.ncbi.nlm.nih.gov

Parkinson's disease: an open label trial of pergolide in patients failing bromocriptine therapy. [2019]

2. United States pubmed.ncbi.nlm.nih.gov

Pergolide therapy in Parkinson's disease: a double-blind, placebo-controlled study. [2019]

3. United States pubmed.ncbi.nlm.nih.gov

Further studies with pergolide in Parkinson disease. [2019]

4. United States pubmed.ncbi.nlm.nih.gov

Pergolide mesylate and idiopathic Parkinson disease. [2019]

5. United States pubmed.ncbi.nlm.nih.gov

Chronic agonist therapy for Parkinson's disease: a 5-year study of bromocriptine and pergolide. [2019]

6. United States pubmed.ncbi.nlm.nih.gov

Drug Safety Data Curation and Modeling in ChEMBL: Boxed Warnings and Withdrawn Drugs. [2023]

7. United Arab Emirates pubmed.ncbi.nlm.nih.gov

Assessment of the health effects of chemicals in humans: II. Construction of an adverse effects database for QSAR modeling. [2019]

8. United States pubmed.ncbi.nlm.nih.gov

Is there a role for the no observed adverse effect level in safety pharmacology? [2021]

9. England pubmed.ncbi.nlm.nih.gov

Ocular adverse drug reactions. [2019]

10. New Zealand pubmed.ncbi.nlm.nih.gov

Depicting Safety Profile of TAAR1 Agonist Ulotaront Relative to Reactions Anticipated for a Dopamine D2-Based Pharmacological Class in FAERS. [2022]