Ignite Creation Date:
2024-05-06 @ 6:55 PM
Last Modification Date:
2024-10-26 @ 2:57 PM
Study NCT ID:
NCT05837624
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-05-30
First Post:
2023-04-12
Brief Title:
EstetrolDrospirenone to Reduce the Average Size of Endometriomas
Sponsor:
McGill University Health CentreResearch Institute of the McGill University Health Centre
Organization:
McGill University Health CentreResearch Institute of the McGill University Health Centre
Study Overview
Official Title:
EstetrolDrospirenone to Reduce the Average Size of Endometriomas
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
ERASE
Brief Summary:
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 dont 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 Estetroldrospirenone 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 endometriomas Consenting participants of the study will take Estetroldrospirenone once daily orally for a 6 month duration An ultrasound assessment of ovarian endometriomas 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
Medical management ie medications and treatments that dont 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 Estetroldrospirenone 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 endometriomas Consenting participants of the study will take Estetroldrospirenone once daily orally for a 6 month duration An ultrasound assessment of ovarian endometriomas 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
Detailed Description:
Ovarian endometriomas or chocolate cysts are present in up to 50 of patients with endometriosis - a chronic gynecological disorder associated with pain and infertility These cysts directly impact fertility and ovarian reserve and can cause additional symptoms in women such as added pain discomfort and surgical emergencies cyst rupture or more rarely torsion
While endometriomas tend to require surgical excision for definitive resolution medical management with a variety of agents has been shown to be effective in reducing their size these agents include combined oral contraceptives COC aromatase inhibitors progestins androgens cabergoline and gonadotropin-releasing hormone agonists GnRH-a Medical management to reduce their size can help alleviate symptoms indefinitely without damaging ovarian reserve prior to fertility treatments or to temporize until surgical management can be offered Medical management has become particularly important in light of the COVID-19 pandemic with significantly reduced access to surgery and resource allocation to alleviate an overburdened healthcare network
Estetroldrospirenone Nextstellis is a prescription-only COC available in Canada containing two hormones a progestin drospirenone - well known as both a standalone contraceptive and in other combined formulations and an estrogen estetrol - newly introduced with this product While ethinyl estradiol EE is the most common estrogen currently used in COC estetrol E4 has proven safety and tolerability and emerging evidence points towards a lower risk of thrombosis than traditional EE used in other COC Studies have documented efficacy and safety for the combination estetroldrospirenone with a favourable bleeding profile and very low rates of adverse reactions While there exists already encouraging data on drospirenone and drospirenone containing products on alleviating symptoms of endometriosis and reducing the size of endometriomas there are no studies to date evaluating this novel combination of estetroldrospirenone in managing ovarian endometriomas
The primary objective of this study is to determine the effectiveness of Estetroldrospirenone a combined oral contraceptive COC in the reduction of ovarian endometriomas after a 3- and 6-month period of treatment
This is a single-center open label single arm interventional study that will be performed at the McGill University Health Centre MUHC Royal Victoria Hospital RVH Women 18 years of age or older with at least one ovarian endometrioma of at least 3cm who are seeking a hormonal treatment for their endometriomas will be recruited The study will aim to recruit 21 women
Consenting participants will be given a 6-month course of oral estetroldrospirenone 15 mg estetrol monohydrate 3 mg drospirenone once daily for the study duration An ultrasound assessment of ovarian endometriomas will be performed prior to drug initiation baseline and will be repeated at 3-months and 6-months time All ultrasounds will be performed by the same ultrasonographer using a standardized technique and 3-D volumetric assessment At each of these hospital visits participants will have their weight and blood pressure measured and they will complete questionnaires regarding their endometriosis symptoms with a research coordinator Safety tolerability and the incidence of adverse effects will also be monitored at the same time intervals
While endometriomas tend to require surgical excision for definitive resolution medical management with a variety of agents has been shown to be effective in reducing their size these agents include combined oral contraceptives COC aromatase inhibitors progestins androgens cabergoline and gonadotropin-releasing hormone agonists GnRH-a Medical management to reduce their size can help alleviate symptoms indefinitely without damaging ovarian reserve prior to fertility treatments or to temporize until surgical management can be offered Medical management has become particularly important in light of the COVID-19 pandemic with significantly reduced access to surgery and resource allocation to alleviate an overburdened healthcare network
Estetroldrospirenone Nextstellis is a prescription-only COC available in Canada containing two hormones a progestin drospirenone - well known as both a standalone contraceptive and in other combined formulations and an estrogen estetrol - newly introduced with this product While ethinyl estradiol EE is the most common estrogen currently used in COC estetrol E4 has proven safety and tolerability and emerging evidence points towards a lower risk of thrombosis than traditional EE used in other COC Studies have documented efficacy and safety for the combination estetroldrospirenone with a favourable bleeding profile and very low rates of adverse reactions While there exists already encouraging data on drospirenone and drospirenone containing products on alleviating symptoms of endometriosis and reducing the size of endometriomas there are no studies to date evaluating this novel combination of estetroldrospirenone in managing ovarian endometriomas
The primary objective of this study is to determine the effectiveness of Estetroldrospirenone a combined oral contraceptive COC in the reduction of ovarian endometriomas after a 3- and 6-month period of treatment
This is a single-center open label single arm interventional study that will be performed at the McGill University Health Centre MUHC Royal Victoria Hospital RVH Women 18 years of age or older with at least one ovarian endometrioma of at least 3cm who are seeking a hormonal treatment for their endometriomas will be recruited The study will aim to recruit 21 women
Consenting participants will be given a 6-month course of oral estetroldrospirenone 15 mg estetrol monohydrate 3 mg drospirenone once daily for the study duration An ultrasound assessment of ovarian endometriomas will be performed prior to drug initiation baseline and will be repeated at 3-months and 6-months time All ultrasounds will be performed by the same ultrasonographer using a standardized technique and 3-D volumetric assessment At each of these hospital visits participants will have their weight and blood pressure measured and they will complete questionnaires regarding their endometriosis symptoms with a research coordinator Safety tolerability and the incidence of adverse effects will also be monitored at the same time intervals
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None