Randomized Trial Assessing Quinagolide Vaginal Ring for Endometriosis-related Pain

  • STATUS
    Recruiting
  • End date
    Aug 25, 2023
  • participants needed
    280
  • sponsor
    Ferring Pharmaceuticals
Updated on 25 December 2020
Investigator
Global Clinical Compliance
Primary Contact
OB/Gyn Associates (6.2 mi away) Contact
+54 other location

Summary

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

Details
Treatment Placebo, Quinagolide 360 µg, Quinagolide 720 µg, Quinagolide 1080 µg
Clinical Study IdentifierNCT03692403
SponsorFerring Pharmaceuticals
Last Modified on25 December 2020

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Eligibility

Yes No Not Sure

Inclusion Criteria

Is your age greater than or equal to 18 yrs?
Are you female?
Do you have Endometriosis Related Pain?
Do you have any of these conditions: Do you have Endometriosis Related Pain??
Do you have any of these conditions: Do you have Endometriosis Related Pain??
Do you have any of these conditions: Do you have Endometriosis Related Pain??
Do you have any of these conditions: Do you have Endometriosis Related Pain??
Do you have any of these conditions: Do you have Endometriosis Related Pain??
Do you have any of these conditions: Do you have Endometriosis Related Pain??
Pre-menopausal females aged 18 years at time of signing informed consent(s)
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
Having moderate to severe endometriosis-related pain
Willing to use a non-hormonal barrier method (i.e. condom) for contraception from randomization to the end-of-trial. This is not required if adequate contraception is achieved by vasectomy of the sexual partner or surgical sterilisation of the subject
Willing to avoid the use of vaginal douches or any other intravaginally administered medications or devices from randomization to the end of treatment
Willing to change usual analgesics to rescue analgesics as permitted by protocol for endometriosis-related pain from the start of run-in to the end-of-trial

Exclusion Criteria

Use of depot medroxyprogesterone acetate (MPA) within 10 months of the start of run-in
Use of gonadotropin releasing hormone (GnRH) agonists (3 months depot) or dopamine agonists within 6 months of the start of run-in
Use of GnRH agonists (1 month depot) or intrauterine device within 3 months of the start of run-in
Use of GnRH antagonist, combined oral contraceptive pill or progestin-only pill within 1 month of the start of run-in
Undiagnosed abnormal vaginal bleeding
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
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