Quinagolide Vaginal Ring for Endometriosis

(RAQUEL Trial)

No longer recruiting at 44 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether a vaginal ring containing different doses of quinagolide, a dopamine agonist, can reduce pain in those with moderate to severe endometriosis-related pain. Participants will receive one of three doses of quinagolide or a placebo to determine which best eases discomfort. Women diagnosed with endometriosis, who have regular menstrual cycles, and experience significant pain during periods may be suitable for this study. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to advancements in managing endometriosis pain.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that quinagolide is generally safe for people. Systems carefully monitor the drug's safety by tracking any side effects. In earlier studies, patients used quinagolide as a vaginal ring, and it was well-tolerated, with most people not experiencing serious side effects.

Researchers are testing quinagolide in different doses: 360 µg, 720 µg, and 1080 µg. So far, these doses have not raised major safety concerns. The studies aim to determine how effectively each dose reduces pain from endometriosis, while also closely monitoring participants' reactions to ensure safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike standard treatments for endometriosis, which often include hormonal therapies and pain relievers, Quinagolide introduces a novel approach with its unique dopamine agonist action. Researchers are excited about Quinagolide because it targets prolactin levels, potentially reducing pain and inflammation differently than typical hormone therapies. Additionally, the innovative vaginal ring delivery system offers a direct and steady release of medication, possibly improving effectiveness and reducing systemic side effects. This method could lead to more personalized and convenient pain management for those suffering from endometriosis.

What evidence suggests that this trial's treatments could be effective for endometriosis-related pain?

Research has shown that the quinagolide vaginal ring might help reduce pain from endometriosis. In this trial, participants will receive different dosages of the quinagolide vaginal ring or a placebo. Studies have found that people using this ring had smaller endometriotic lesions. Specifically, fewer lesions grew larger compared to those not using the treatment. Quinagolide likely works by affecting certain hormones that help these lesions grow. While more research is needed, early results suggest it could be a promising option for managing endometriosis-related pain. ^{1 2 6 7 8}

Who Is on the Research Team?

Global Clinical Compliance

Principal Investigator

Ferring Pharmaceuticals

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Quinagolide

How Is the Trial Designed?

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

Published Research Related to This Trial

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]

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 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]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40188683/

Quinagolide vaginal ring for reduction of endometriotic ... This study evaluated the effectiveness of quinagolide vaginal ring on reducing total lesion size in endometrioma, deep infiltrating endometriosis (DIE), and ...

2. sciencedirect.com sciencedirect.com/science/article/pii/S0301211525002118

Quinagolide vaginal ring for reduction of endometriotic ... Efficacy outcomes ; Endometrioma, n (%) ; Subjects with lesion volume progression, 9/24 (37.5 %), 9/24 (37.5 %) ; Lesions with volume progression, 13/55 (23.6 %) ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03692403

Randomized Trial Assessing Quinagolide Vaginal Ring for ... A Randomized, Double-blind, Placebo-controlled, Phase 2 Trial Assessing the Efficacy, Safety and Dose-response of Quinagolide Extended-release Vaginal Rings ...

4. clinicaltrials.gov clinicaltrials.gov/study/NCT03749109

NCT03749109 | Quinagolide Vaginal Ring on Lesion ... Quinagolide vaginal ring for reduction of endometriotic lesions: Results from the QLARITY trial. Eur J Obstet Gynecol Reprod Biol. 2025 Jun;310:113946. doi ...

5. mayo.edu mayo.edu/research/clinical-trials/cls-20468263

A Study to Assess the Quinagolide Vaginal Ring for ... The purpose of this study is to evaluate the effectiveness of three doses of quinagolide administered as an extended-release vaginal ring compared to ...

6. withpower.com withpower.com/trial/phase-3-endometriosis-10-2018-beaa4

Randomized Trial Assessing Quinagolide Vaginal Ring for ... Is Quinagolide generally safe for humans? The safety of Quinagolide, like other drugs, is monitored through databases that track adverse drug reactions (ADRs).

7. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/03/NCT03692403/Prot_000.pdf

Cover Page for Protocol Quinagolide vaginal ring is an extended-release system with a dose load of quinagolide 360 µg,. 720 µg and 1080 µg at a target daily release ...

8. ctv.veeva.com ctv.veeva.com/study/randomized-trial-assessing-quinagolide-vaginal-ring-for-endometriosis-related-pain

Randomized Trial Assessing Quinagolide Vaginal Ring for ... Vaginal ring containing Quinagolide 360 μg, with daily target release rate of 4.5 μg. Treatment: Drug: Quinagolide 360 µg. Quinagolide 720 µg.