A Phase 4 interventional study of Ulipristal Acetate in Adenomyosis, Heavy Uterine Bleeding and Dysmenorrhea, sponsored by Vanderbilt University Medical Center. Withdrawn at 1 site in United States. Open to female participants aged 18 Years to 51 Years. Per ClinicalTrials.gov, last updated 2018-02-08.
Sponsored by Vanderbilt University Medical Center · Phase 4, Interventional, and Treatment
Among 16 studies in Adenomyosis with a site in United States — 3 open to participants now, 5 under way, none of them phase 3. Adenomyosis · United States.
Among the 16 studies in Adenomyosis with a site in United States, this one is the 13th largest by enrollment of the 14 interventional ones, is the only one that started in 2018, is one of 3 in phase 4, and was the 9th registered.
142 studies on the registry are indexed under Adenomyosis; 54 are open to participants now.
Browse Adenomyosis studies →3 of the 16 studies in Adenomyosis with a site in United States are open now, in 1 country. Each count lists the studies.
Of the 29 Adenomyosis studies recruiting now, 8 (28%) set no upper age limit and 21 (72%) stop at 75 or younger; 2 take children under 18; 9 take healthy volunteers.
This study: 18 Years to 51 Years · female · no healthy volunteers.
The full table on the hub →16 studies; the count open now beside each. This study's row is marked.
First in 2011; this study’s year is marked. 1 started in 2018.
Median enrollment 45 across the 14 interventional studies, 39 across the 2 observational. Of the 9 that completed or were terminated, 3 (33%) have results posted.
2 of 16 have an industry lead sponsor. The 10 most frequent:
Vanderbilt University Medical Center is the lead sponsor of 833 studies on the registry; 155 are open to participants now.
Of its 125 completed or terminated interventional studies of FDA-regulated products, 92 (74%) have results posted.
Vanderbilt University Medical Center has 1 study filed under Adenomyosis — fewer than ten, so there is no comparison to draw.
None of the studies under way reaches primary completion within a year.
Among the 16 studies in Adenomyosis with a site in United States, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BMI (body mass index)
Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.
What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Ulipristal acetate 5mg daily for 12 weeks
Drug: Ulipristal Acetate
Ulipristal 5mg daily by mouth for 12 weeks
Also known as: Fibristal
Bleeding patterns
Patient will use the pictorial blood loss assessment chart (PBAC) to describe bleeding patterns
Time frame: 6 months
Quality of life
Patient will complete menorrhagia impact questionnaire (0-100, 0 is worst and 100 is best quality of life)
Time frame: 6 months
Pain
Patient will complete pain scale (0-10, 0 is no pain and 10 is worst pain)
Time frame: 6 months
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Feb 2018; primary completion for May 2019, 15 months later.
How these figures are worked out, and which studies are left out of them.
This study is withdrawn, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ulipristal acetate
Vanderbilt University Medical Center →