Randomized Trial Assessing Quinagolide Vaginal Ring for Endometriosis-related Pain (RAQUEL)

Ferring

Status and phase: Completed; Phase 2

Conditions: Endometriosis-related Pain

Treatments: Drug: Quinagolide 1080 µg; Drug: Placebo; Drug: Quinagolide 720 µg; Drug: Quinagolide 360 µg

Study type: Interventional

Funder types: Industry

Identifiers

NCT03692403

000165

Details and patient eligibility

About

To evaluate the efficacy of three doses of quinagolide administered as an extended-release vaginal ring compared to placebo on reduction of moderate to severe endometriosis-related pain

Enrollment: 22 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Pre-menopausal females aged ≥18 years at time of signing informed consent(s) with regular menstrual cycles.
• 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.
• Eligible participants experienced moderate to severe endometriosis-related pain, which was defined as at the run-in visit, the participant having an NRS score of ≥5 for the worst endometriosis related pain during the past menstrual cycle and at randomization, the participant having a mean daily NRS score of ≥4 for the worst endometriosis related pain during each run-in menstrual cycle.

Exclusion criteria

• History of no relief of endometriosis related pain after any medical therapy or surgery. However, history of partial pain relief, discontinuation due to side effects are not exclusionary.
• Known bone diseases (e.g. osteoporosis, Paget's disease and osteomalacia) affecting bone resorption or bone formation markers.
• Any significant abnormal findings of heart examinations before randomization.
• History of mental illness including occurrence of acute psychosis, bipolar disorders and schizophrenia (except for well-controlled anxiety and/or depression with no changes to interventions for 6 months prior to start of run-in)
• History of impulse control disorders including pathological gambling, compulsive buying, hypersexuality, and binge eating or being identified with potential impulse control disorder by the questionnaire for impulsive-compulsive disorders (a score ≥2 for any sub-questions of Question 3 or a score ≥1 for any sub-questions of Question 4) prior to randomization.
• History of orthostatic hypotension or recurrent syncope.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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22 participants in 4 patient groups, including a placebo group

Quinagolide 360 µg

Experimental group

Description:

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

Treatment:

Drug: Quinagolide 360 µg

Quinagolide 720 µg

Experimental group

Description:

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

Treatment:

Drug: Quinagolide 720 µg

Quinagolide 1080 µg

Experimental group

Description:

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

Treatment:

Drug: Quinagolide 1080 µg

Placebo

Placebo Comparator group

Description:

Vaginal ring containing matching placebo

Treatment:

Drug: Placebo