Can Intrauterine Levonorgestrel Releasing Device Be a Treatment Option for Postmenstrual Spotting in Isthmocele

NCT04872244 | Completed FDA Device

• 1 other identifier: GaziosmanpasaTREHB
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Isthmocele; Post-menstrual Spotting Bleeding; Pelvic Pain

Keywords

isthmocele; postmenstrual spotting bleeding; pelvic pain

Outcome Measures

Primary Outcomes (3)

• incidence of postmenstrual spotting bleeding

  incidence of vaginal spotting bleeding after normal menstrual bleeding

  18 months

• incidence of dysmenorrhea

  incidence of pelvic pain felt by the patient during mensturation

  18 months

• incidence of pelvic pain

  incidence of pelvic pain regardless of mensturation

  18 months

Study Arms (1)

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

Device: usage of mirena ( levonorgestrel releasing intrauterine device) in isthmocele; Drug: Levonorgestrel Drug Implant Product

Interventions

usage of mirena ( levonorgestrel releasing intrauterine device) in isthmocele DEVICE

usage of mirena ( levonorgestrel releasing intrauterine device) in isthmocele for postmenstrual spotting and do not have desire for fertility

Also known as: levonorgestrel

patients with isthmosele that mirena ( levonorgestrel releasing intrauterine device) was applied

Levonorgestrel Drug Implant Product DRUG

intrauterine administration

patients with isthmosele that mirena ( levonorgestrel releasing intrauterine device) was applied

Eligibility Criteria

• Age: 30 Years - 40 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Gaziosmanpasa Research and Education Hospital: lead

Study Sites (1)

saglik Bilimleri Univercity Gaziosmanpaşa Training and Research Hospital

Istanbul, 34245, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Pelvic Pain

Condition Hierarchy (Ancestors)

Pain; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr.

Model Details: patients who have isthmocele due to previous cesarean section and suffering from postmenstrual spotting bleeding

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: May 4, 2021
• Study Start: November 3, 2019
• Primary Completion: June 3, 2021
• Study Completion: July 12, 2021
• Last Updated: August 25, 2021

Record last verified: 2020-06

Locations

TU (1)