IsthmoceleNCT04872244
Can Intrauterine Levonorgestrel Releasing Device Be a Treatment Option for Postmenstrual Spotting in Isthmocele
A study testing usage of mirena ( levonorgestrel releasing intrauterine device) in isthmocele and Levonorgestrel Drug Implant Product in people with Isthmocele and Post-menstrual Spotting Bleeding, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
Trial summary
it was planned to investigate the treatment effect of levonorgestrel releasing intrauterine device in patient with isthmocele who were suffering from postmenstrual spotting bleeding and who had no desire for fertility. Read more about this study
- Who is it for?
- Ages 30 to 40 years, women only
- Conditions the study is for
- Isthmocele, Post-menstrual Spotting Bleeding, Pelvic Pain
- What is being tested?
- usage of mirena ( levonorgestrel releasing intrauterine device) in isthmocele and Levonorgestrel Drug Implant Product
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 3 Nov 2019to 12 Jul 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- having isthmocele and complaining for postmestrual spotting bleeding
- having cesarean section as a last delivery way.
- not planning for fertility
- complaining about dysmenorrhea and pelvic pain
Who cannot join
- having pelvic infection
- having an any type of previous pelvic surgery
- having leiomyoma, endometrial polyp or adnexal mass
- having any type of malignancy
- having thyroid dysfunction and prolactinemia
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
saglik Bilimleri Univercity Gaziosmanpaşa Training and Research Hospital
Istanbul, 34245
About this study
Official title: Results of Intrauterine Levonorgestrel Use for the Patients With Isthmocele Suffering From Postmenstrual Spotting Without Fertility Desire
it was planned to investigate the treatment effect of levonorgestrel releasing intrauterine device in patient with isthmocele who were suffering from postmenstrual spotting bleeding and who had no desire for fertility.
Read the detailed description
isthmocele is an acquired diverticulum like defect of myometrium in the anterior isthmic part of uterus due to previous cesarean section incision. It can be defined as thinning of the incised site of uterus smaller than 50 % of its normal thickness. the real incidence is unknown. due to low ability of contractility of the postmenstrual spotting bleeding. Accumulation of blood in the isthmocele induces inflammation within the endometrium and causes pain as well. Furthermore, this inflammation can be an absolute reason for secondary infertility. As a result, accumulation of blood in the isthmocele seems to start up the cascade of morbidities. When understanding the mechanism, preventing blood accumulation seems to prevent symptoms other than infertility. Levonorgestrel releasing intrauterine devices can be a way of thinning the endometrium hence, blood accumulation can be avoided. In the literature, surgical correction of the isthmocele has been studied and medical treatment that was mentioned in the literature was the oral contraceptives and only a preliminary report of very small sample size, discussed the effect of levonorgestrel releasing device . in the light of aforementioned clinical knowledge, we planned to investigate the treatment effect of levonorgestrel releasing intrauterine device in patients with postmenstrual bleeding due to isthmocele who were not willing to have baby. These patients will be called back at 6th, 12th and 18th months after applying levonorgestrel releasing device to the uterus. Gynecological examinations will be done and complainants will be questioned.
- Conditions
- Isthmocele, Post-menstrual Spotting Bleeding, Pelvic Pain
- Being tested
- usage of mirena ( levonorgestrel releasing intrauterine device) in isthmocele, Levonorgestrel Drug Implant Product
- Keywords
- isthmocele, postmenstrual spotting bleeding, pelvic pain
- Medical subject headings
- Pelvic Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
usage of mirena ( levonorgestrel releasing intrauterine device) in isthmoceleDevice
Also called levonorgestrel
usage of mirena ( levonorgestrel releasing intrauterine device) in isthmocele for postmenstrual spotting and do not have desire for fertility
Levonorgestrel Drug Implant ProductDrug
intrauterine administration
| Study group | Role | What they receive |
|---|---|---|
| patients with isthmosele that mirena ( levonorgestrel releasing intrauterine device) was applied | Experimental | outcome measures of patients suffering from postmenstruel spotting due to ısthmosele whom mirena ( levonorgestrel releasing intrauterine device) was applied Receives: Device: usage of mirena ( levonorgestrel releasing intrauterine device) in isthmocele; Drug: Levonorgestrel Drug Implant Product |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of postmenstrual spotting bleeding
incidence of vaginal spotting bleeding after normal menstrual bleeding
Measured: 18 months
incidence of dysmenorrhea
incidence of pelvic pain felt by the patient during mensturation
Measured: 18 months
incidence of pelvic pain
incidence of pelvic pain regardless of mensturation
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2021
- Study start3 Nov 2019
- Primary completion3 Jun 2021
- Study completion12 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IsthmoceleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- patients who have isthmocele due to previous cesarean section and suffering from postmenstrual spotting bleeding
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gaziosmanpasa Research and Education Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Fatma ketenci gencer, Gaziosmanpasa Research and Education Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04872244
- Sponsor's protocol ID
- GaziosmanpasaTREHB
- Status last verified
- Jun 2020
- First submitted
- 15 Jun 2020
- Last updated
- 25 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Results of Intrauterine Levonorgestrel Use for the Patients With Isthmocele Suffering From Postmenstrual Spotting Without Fertility Desire
- ClinicalTrials.gov ID
- NCT04872244
- Acronym / sponsor ID
- GaziosmanpasaTREHB
- Conditions
- Isthmocele, Post-menstrual Spotting Bleeding, Pelvic Pain
- Keywords
- isthmocele, postmenstrual spotting bleeding, pelvic pain
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Gaziosmanpasa Research and Education HospitalOther government
- Study start
- 3 Nov 2019 (actual)
- Primary completion
- 3 Jun 2021 (actual)
- Study completion
- 12 Jul 2021 (actual)
- First posted
- 4 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
it was planned to investigate the treatment effect of levonorgestrel releasing intrauterine device in patient with isthmocele who were suffering from postmenstrual spotting bleeding and who had no desire for fertility.
Detailed description
isthmocele is an acquired diverticulum like defect of myometrium in the anterior isthmic part of uterus due to previous cesarean section incision. It can be defined as thinning of the incised site of uterus smaller than 50 % of its normal thickness. the real incidence is unknown. due to low ability of contractility of the postmenstrual spotting bleeding. Accumulation of blood in the isthmocele induces inflammation within the endometrium and causes pain as well. Furthermore, this inflammation can be an absolute reason for secondary infertility. As a result, accumulation of blood in the isthmocele seems to start up the cascade of morbidities. When understanding the mechanism, preventing blood accumulation seems to prevent symptoms other than infertility. Levonorgestrel releasing intrauterine devices can be a way of thinning the endometrium hence, blood accumulation can be avoided. In the literature, surgical correction of the isthmocele has been studied and medical treatment that was mentioned in the literature was the oral contraceptives and only a preliminary report of very small sample size, discussed the effect of levonorgestrel releasing device . in the light of aforementioned clinical knowledge, we planned to investigate the treatment effect of levonorgestrel releasing intrauterine device in patients with postmenstrual bleeding due to isthmocele who were not willing to have baby. These patients will be called back at 6th, 12th and 18th months after applying levonorgestrel releasing device to the uterus. Gynecological examinations will be done and complainants will be questioned.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- patients who have isthmocele due to previous cesarean section and suffering from postmenstrual spotting bleeding
| Arm | Type | Receives |
|---|---|---|
| patients with isthmosele that mirena ( levonorgestrel releasing intrauterine device) was applied | Experimental | Device: usage of mirena ( levonorgestrel releasing intrauterine device) in isthmocele, Drug: Levonorgestrel Drug Implant Productoutcome measures of patients suffering from postmenstruel spotting due to ısthmosele whom mirena ( levonorgestrel releasing intrauterine device) was applied |
Who may qualify
- Ages
- 30 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- having isthmocele and complaining for postmestrual spotting bleeding
- having cesarean section as a last delivery way.
- not planning for fertility
- complaining about dysmenorrhea and pelvic pain
Key exclusion criteria (5 listed)
- having pelvic infection
- having an any type of previous pelvic surgery
- having leiomyoma, endometrial polyp or adnexal mass
- having any type of malignancy
- having thyroid dysfunction and prolactinemia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| usage of mirena ( levonorgestrel releasing intrauterine device) in isthmoceleAlso: levonorgestrelusage of mirena ( levonorgestrel releasing intrauterine device) in isthmocele for postmenstrual spotting and do not have desire for fertility | Device | patients with isthmosele that mirena ( levonorgestrel releasing intrauterine device) was applied |
| Levonorgestrel Drug Implant Productintrauterine administration | Drug | patients with isthmosele that mirena ( levonorgestrel releasing intrauterine device) was applied |
Primary outcome
incidence of postmenstrual spotting bleeding
Time frame: 18 months
incidence of vaginal spotting bleeding after normal menstrual bleeding
incidence of dysmenorrhea
Time frame: 18 months
incidence of pelvic pain felt by the patient during mensturation
incidence of pelvic pain
Time frame: 18 months
incidence of pelvic pain regardless of mensturation
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Aug 2021.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing usage of mirena ( levonorgestrel releasing intrauterine device) in isthmocele and Levonorgestrel Drug Implant Product in people with Isthmocele and Post-menstrual Spotting Bleeding, run by Gaziosmanpasa Research and Education Hospital at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
incidence of postmenstrual spotting bleeding (time frame: 18 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Aug 2021.