Effect of Ulipristal Acetate on Bleeding Patterns & Dysmenorrhea in Women

Status Withdrawn

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

Clinical Trial Details

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Status	Withdrawn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

View Details

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	`NCT00746096` - Efficacy and Safety Study of Low Dose Oral Contraceptive Pill to Treat Primary Dysmenorrhea	Phase 3
Completed	`NCT00769964` - VA111913 TS: First in Human Study	Phase 1
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

Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.

Effect of Ulipristal Acetate on Bleeding Patterns and Dysmenorrhea in Women With Adenomyosis

Clinical Trial Summary

Clinical Trial Description

Study Design

Related Conditions & MeSH terms