Clinical Trials Logo

Clinical Trial Summary

Adenomyosis affects approximately 21% of symptomatic women who present to gynecology clinics. The disease is characterized by heavy bleeding and pain during periods. Limited treatment options exist for the treatment of adenomyosis for women who desire future child-bearing or prefer to avoid surgery. Recently, ulipristal acetate has been studied as a treatment option for women who have fibroids and heavy bleeding. The majority of women treated with ulipristal stopped having periods altogether. Our study aims to determine whether ulipristal is an adequate treatment for women with adenomyosis.


Clinical Trial Description

Adenomyosis affects an estimated 20.9% of symptomatic women who present to gynecology clinics, with peak prevalence of 32% in 40-49 years old. Prior histologic studies in women undergoing hysterectomy show prevalence of with some variation due to differing histologic diagnostic criteria 10-37.1%. Heavy menstrual bleeding and dysmenorrhea are commonly manifested in women with adenomyosis. However, data on treatment of adenomyosis remains scarce. For women desiring definitive options, hysterectomy remains the treatment of choice. However, for women who desire future fertility, the currently accepted first-line therapy is progestogen therapy, particularly the levonorgestrel-IUD. Other limited studies have used danazol and GnRH agonists, but its use is limited by significant side effects.

Recently, the selective progesterone receptor modulators (SPRM) have emerged as successful medical treatment options for leiomyoma. The SPRM ulipristal acetate has been studied extensively in the treatment of leiomyoma and more recently endometriosis. Ulipristal acetate exerts both antagonist and agonist properties. Amenorrhea was achieved in 80% of women taking 5mg of ulipristal daily by treatment month 2 and up to 90% of women taking 10mg daily. Anovulation was achieved in 80% of women taking 5mg and 10mg dosing. Ulipristal acetate has not been studied as a treatment option for women with adenomyosis. We aim to study the effect of daily ulipristal on heavy menstrual bleeding in women with adenomyosis. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT03325868
Study type Interventional
Source Vanderbilt University Medical Center
Contact
Status Withdrawn
Phase Phase 4
Start date February 2018
Completion date May 2019

See also
  Status Clinical Trial Phase
Completed NCT04607382 - Survey on Menstrual Symptoms, Health Related Quality of Life and Work Productivity in Patients Suffering From Pain During Menstruation (Dysmenorrhea) in Japan
Recruiting NCT04091789 - Sublingual Tablets With Cannabinoid Combinations for the Treatment of Dysmenorrhea Phase 2
Completed NCT00769964 - VA111913 TS: First in Human Study Phase 1
Completed NCT00746096 - Efficacy and Safety Study of Low Dose Oral Contraceptive Pill to Treat Primary Dysmenorrhea Phase 3
Completed NCT00104546 - Vitamin K Injections for the Treatment of Painful Menstruation Phase 1
Completed NCT06011928 - MOPEXE and RE in Treating Dysmenorrhea N/A
Not yet recruiting NCT06398990 - The Effect of Cognitive Exercise Therapy Approach and Yoga in Adolescents With Dysmenorrhoea N/A
Recruiting NCT02031523 - Multi-center Clinical Trials of Sanjie Analgesic Capsule in Treating Endometriosis Phase 4
Completed NCT01449305 - Effectiveness of Nanoone Woman Underwear Using in the Management of Dysmenorrhea N/A
Completed NCT00995917 - A Pilot Study of Acupoint Injection for Primary Dysmenorrhea N/A
Completed NCT02910167 - Observational Prospective Study to Evaluate AEs, Risk Factors and Drug Utilization of BUSCAPINA COMPOSITUM N in Adults From Metropolitan Lima
Not yet recruiting NCT05461846 - Effect of Integrated Neuromuscular Inhibition Technique in Females With Menstrual Low Back Pain N/A
Completed NCT05247333 - Implementation of a Minor Ailment Service in Community Pharmacy Practice N/A
Not yet recruiting NCT03697746 - Comparison of Dexketoprofen, Paracetamol and Ibuprofen in the Treatment of Primary Dysmenorrhea N/A
Recruiting NCT03394547 - Pulsed Electromagnetic Field Treatment for Painful Periods N/A
Recruiting NCT06294743 - Posterior Tibia Nerve Neuroprolotherapy for Dysmenorrhea Early Phase 1
Active, not recruiting NCT01738204 - The Women's Health Study: From Adolescence to Adulthood
Completed NCT01462370 - Study to Assess the Safety and Efficacy of Etoricoxib Versus Ibuprofen in the Treatment of Dysmenorrhea (MK-0663-145 AM1) Phase 3
Completed NCT01250587 - Dose-Finding Study of PDC31 in Patients With Primary Dysmenorrhea Phase 1
Completed NCT00951561 - A Comparison Study of Pain Relief From Dysmenorrhea Between the Vipon Tampon and Ibuprofen N/A