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Last Updated: November 2, 2024

CLINICAL TRIALS PROFILE FOR KYLEENA


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All Clinical Trials for KYLEENA

Trial ID Title Status Sponsor Phase Start Date Summary
NCT03657602 ↗ Immediate Postpartum Insertion of Contraceptive Intrauterine Devices Recruiting University of Oklahoma Early Phase 1 2019-12-15 In this randomized trial, investigators intend to determine the expulsion and discontinuation rate of immediate postpartum intrauterine devices in the patient population of the University of Oklahoma Women's Healthcare Specialists Clinic (OUWHSC).
NCT05570786 ↗ Subdermal Implant-bioabsorbable Gestrinone Pellet for Endometriosis Pelvic Pain Treatment Not yet recruiting Biós Farmacêutica Phase 2 2022-11-01 Pelvic pain is considered a symptom of multifactorial origin among which Endometriosis is the main gynecological cause affecting 5-10% of worldwide women in their reproductive years, negatively impacting their quality of life and work efficiency. Treatment of endometriosis-associated pelvic pain is challenging and there are surgical and/or hormonal treatments available with variable endpoints. Gestrinone is a synthetic derivative of 19-nortestosterone with anti-estrogen, anti-progestin, androgenic, and weak estrogen-like action. Previous studies show that the oral treatment with Gestrinone induced an improvement in symptoms associated with endometriosis but with adverse events such as androgenization and uterine bleeding. Parenteral administration of Gestrinone could be effective to treat pain symptoms secondary to endometriosis and minimize these adverse events. This study evaluates the safety and tolerability of subdermal implant-bioabsorbable gestrinone pellet use in women with pelvic pain secondary to endometriosis after 6 months of Gestrinone pellet insertion versus placebo pellet.
NCT05570786 ↗ Subdermal Implant-bioabsorbable Gestrinone Pellet for Endometriosis Pelvic Pain Treatment Not yet recruiting Science Valley Research Institute Phase 2 2022-11-01 Pelvic pain is considered a symptom of multifactorial origin among which Endometriosis is the main gynecological cause affecting 5-10% of worldwide women in their reproductive years, negatively impacting their quality of life and work efficiency. Treatment of endometriosis-associated pelvic pain is challenging and there are surgical and/or hormonal treatments available with variable endpoints. Gestrinone is a synthetic derivative of 19-nortestosterone with anti-estrogen, anti-progestin, androgenic, and weak estrogen-like action. Previous studies show that the oral treatment with Gestrinone induced an improvement in symptoms associated with endometriosis but with adverse events such as androgenization and uterine bleeding. Parenteral administration of Gestrinone could be effective to treat pain symptoms secondary to endometriosis and minimize these adverse events. This study evaluates the safety and tolerability of subdermal implant-bioabsorbable gestrinone pellet use in women with pelvic pain secondary to endometriosis after 6 months of Gestrinone pellet insertion versus placebo pellet.
NCT05875571 ↗ Intravenous Ketorolac Administration to Attenuate Post-procedural Pain Associated With Intrauterine Device Placement Not yet recruiting Arkansas Children's Hospital Research Institute Phase 4 2023-09-01 Intrauterine devices (IUDs) are a popular form of long-acting reversible contraception, with a high efficacy rate and few side effects. The insertion procedure for IUDs can be uncomfortable and painful. Sedation may be needed to improve patient comfort. The use of IUDs is increasing in the adolescent population, but perceived pain is a barrier to placement. Propofol is a commonly used agent for pediatric procedural sedation, but it has no analgesic properties. Ketorolac, a nonsteroidal anti-inflammatory drug, has been shown to reduce pain in adults and improve patient satisfaction when used prior to IUD placement.. The current study aims to determine if ketorolac, given in combination with propofol for IUD placement in adolescents, can improve comfort during placement and reduce pain following the procedure. Enrolled patients will receive ketorolac or placebo, in addition to propofol, for IUD placement. By comparing the outcomes of these two groups of patients, we can gain a better understanding of the optimal approach to sedation for IUD insertion in adolescents.
>Trial ID >Title >Status >Phase >Start Date >Summary

Clinical Trial Conditions for KYLEENA

Condition Name

Condition Name for KYLEENA
Intervention Trials
Contraception 2
Pelvic Pain 1
Deep Endometriosis 1
Healthy Female 1
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Condition MeSH

Condition MeSH for KYLEENA
Intervention Trials
Pain, Procedural 1
Pelvic Pain 1
Endometriosis 1
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Clinical Trial Locations for KYLEENA

Trials by Country

Trials by Country for KYLEENA
Location Trials
Brazil 1
United States 1
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Trials by US State

Trials by US State for KYLEENA
Location Trials
Oklahoma 1
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Clinical Trial Progress for KYLEENA

Clinical Trial Phase

Clinical Trial Phase for KYLEENA
Clinical Trial Phase Trials
Phase 4 1
Phase 2 1
Early Phase 1 1
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Clinical Trial Status

Clinical Trial Status for KYLEENA
Clinical Trial Phase Trials
Not yet recruiting 2
Recruiting 1
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Clinical Trial Sponsors for KYLEENA

Sponsor Name

Sponsor Name for KYLEENA
Sponsor Trials
Arkansas Children's Hospital Research Institute 1
University of Oklahoma 1
Biós Farmacêutica 1
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Sponsor Type

Sponsor Type for KYLEENA
Sponsor Trials
Other 4
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