Estetrol/Drospirenone to Reduce the Average Size of Endometriomas
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexFemale
Age18+
SponsorAndrew Zakhari
About this trial
Endometriosis, a chronic gynecological disorder associated with pain and infertility, is a common condition affecting approximately one in ten women. Up to 50% of patients with endometriosis have ovarian endometriomas (or "chocolate cysts"). These cysts directly impact fertility and ovarian reserve (ie. ability to have children) and can cause additional symptoms in women such as added pain, discomfort, and surgical emergencies (cyst rupture, or more rarely twisting). While endometriomas tend to require surgical excision as a solution, medical management with a variety of medications has been shown to be effective in reducing their size.
Medical management (ie. medications and treatments that don't involve surgery) to reduce cyst size can help relieve symptoms either as a long term solution, before fertility treatments, or temporarily until surgery can be offered. Because the COVID-19 pandemic caused significantly reduced access to surgery and resources, medical management has become important for relief of the overburdened healthcare network.
The purpose of this study is to see how effective Estetrol/drospirenone, a combined oral contraceptive (COC), is in the reduction of ovarian endometriomas after a 3- and 6-month period of treatment.
This single arm interventional study will recruit women 18 years or older with an ovarian endometrioma of at least 3cm, who are seeking a hormonal treatment for their endometrioma(s). Consenting participants of the study will take Estetrol/drospirenone once daily, orally, for a 6 month duration. An ultrasound assessment of ovarian endometrioma(s) will be performed before starting the drug (0 months), and will be repeated at 3-months and 6-months time. At each of these hospital visits (0, 3 \& 6 months), participants will have their weight and blood pressure measured, and they will complete questionnaires regarding their endometriosis symptoms, incidence of amenorrhea, compliance and incidence of any adverse effects.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Equal to or greater than 18 years old
Has at least one ovarian endometrioma, of at least 3 cm
Seeking a hormonal treatment for their endometrioma(s)
Disqualifiers
Any allergy or contraindication to the study drug
Inability to provide informed consent
Any hormone use, from the following list, within last 3 months (excluding hormones used for ovarian stimulation for fertility treatments): Estrogen (agonist or antagonist), Progestogen (agonist or antagonist), Androgen (agonist or antagonist), GnRH (agonist or antagonist), Cabergoline
Trial design
Design model
Single group
Treatments tested in this trial
Estetrol/Drospirenone
Drug6-month course of oral estetrol/drospirenone (15 mg estetrol monohydrate / 3 mg drospirenone) once daily for the study duration
Treatment groups
21 Participants
are divided into 1 treatment groupGroup A: Women with an ovarian endometrioma who will take drospirenone / estetrolExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Change in ovarian endometrioma volume at 6-months (from baseline)
Endometrioma volume will be assessed by the same ultrasonographer (Dr. DB Nguyen) at each hospital visit, using a standardized technique, with 3-dimensional volumetric assessment.
Time frame
pre-study, 6-months of treatmentSecondary outcomes
1
Change in endometrioma volume at 3-months (from baseline)
Endometrioma volume will be assessed by the same ultrasonographer (Dr. DB Nguyen) at each hospital visit, using a standardized technique, with 3-dimensional volumetric assessment.
Time frame
pre-study, 3-months of treatment2
change in endometrioma maximal diameter at 6-months (from baseline)
Endometrioma maximal diameter will be assessed by the same ultrasonographer (Dr. DB Nguyen) at each hospital visit, using a standardized technique, with 3-dimensional volumetric assessment.
Time frame
pre-study, 6-months of treatment3
change in endometrioma maximal diameter at 3-months (from baseline)
Endometrioma maximal diameter will be assessed by the same ultrasonographer (Dr. DB Nguyen) at each hospital visit, using a standardized technique, with 3-dimensional volumetric assessment.
Time frame
pre-study, 3-months of treatment4
Incidence of amenorrhea
Incidence of amenorrhea will be evaluated by having the participant complete a questionnaire at each hospital visit. * If they have gotten their period in the last 3 months: measured by (yes/no) * The frequency of spotting in the last month: measured by a 4-point likert scale (Never/Rarely/Occasionally/Often)
Time frame
pre-study, 3-months of treatment, 6-months of treatmentSponsors and contacts
Click on the lead sponsor to view all of their trials.
Andrew Zakhari
Lead sponsor
McGill University Health Centre/Research Institute of the McGill University Health Centre
Sponsor institution
Source ClinicalTrials.gov