Ella (Ulipristal Acetate) - Summary

ELLA SUMMARY

The ella (ulipristal acetate) tablet for oral use contains 30 mg of a single active steroid ingredient, ulipristal acetate, a synthetic progesterone agonist/antagonist.

ella is a progesterone agonist/antagonist emergency contraceptive indicated for prevention of pregnancy following unprotected intercourse or a known or suspected contraceptive failure. ella is not intended for routine use as a contraceptive.

See all Ella indications & dosage >>

NEWS HIGHLIGHTS

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Published Studies Related to Ella (Ulipristal)

Ulipristal acetate versus levonorgestrel for emergency contraception: a randomised non-inferiority trial and meta-analysis. [2010.02.13]
BACKGROUND: Emergency contraception can prevent unintended pregnancies, but current methods are only effective if used as soon as possible after sexual intercourse and before ovulation. We compared the efficacy and safety of ulipristal acetate with levonorgestrel for emergency contraception... INTERPRETATION: Ulipristal acetate provides women and health-care providers with an effective alternative for emergency contraception that can be used up to 5 days after unprotected sexual intercourse. FUNDING: HRA Pharma. Copyright 2010 Elsevier Ltd. All rights reserved.

Immediate pre-ovulatory administration of 30 mg ulipristal acetate significantly delays follicular rupture. [2010]
mm... CONCLUSIONS: This study demonstrates that UPA can significantly delay follicular

Randomised comparison of the FerX Ella antireflux stent and the ultraflex stent: proton pump inhibitor combination for prevention of post-stent reflux in patients with esophageal carcinoma involving the esophago-gastric junction. [2008.05]
BACKGROUND AND AIM: Metal stents placed across the gastroesophageal junction in patients with malignant dysphagia frequently present with reflux symptoms. We compared an antireflux stent with a standard open stent used in combination with proton pump inhibitor medication... CONCLUSION: The antireflux stent had no demonstrable advantages compared to the combination of standard open stent and proton pump inhibitor medication.

Can we identify women at risk of pregnancy despite using emergency contraception? Data from randomized trials of ulipristal acetate and levonorgestrel. [2011.10]
BACKGROUND: Emergency contraception (EC) does not always work. Clinicians should be aware of potential risk factors for EC failure... CONCLUSIONS: Women who have intercourse around ovulation should ideally be offered a copper intrauterine device. Women with body mass index >25 kg/m(2) should be offered an intrauterine device or UPA. All women should be advised to start effective contraception immediately after EC. Copyright (c) 2011 Elsevier Inc. All rights reserved.

Ulipristal acetate for emergency contraception. [2011.06]
CONCLUSIONS: Ulipristal acetate is effective as an emergency contraceptive for up to 120 hours after unprotected intercourse. Because ulipristal is available only via prescription, it may be covered by insurance. However, the additional factors of travel expenses and time to make and attend a physician appointment must be taken into account when considering use of ulipristal as an emergency contraceptive. Due to the similarity of its structure to mifepristone, controversy regarding ulipristal's mechanism of action has arisen.

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Clinical Trials Related to Ella (Ulipristal)

SX ELLA Esophageal Degradable BD Stent System [Recruiting]

CDB-2914 for Abnormal Uterine Bleeding in Premenopausal Women [Not yet recruiting]
Background:

- CDB-2914 is a hormone that blocks progesterone, which is necessary for maintaining

pregnancy. In women with fibroid tumors, CDB-2914 shrank the tumors. In many cases, menstrual periods stopped during treatment. Because CDB-2914 decreased or stopped menstrual bleeding in women with fibroids, it may be able to treat abnormal periods in women without fibroids.

Objectives:

- To see whether CDB-2914 can treat abnormal uterine bleeding in premenopausal women.

Eligibility:

- Premenopausal women who have abnormal uterine bleeding that is not caused by fibroids.

Design:

- Participants will be screened with a physical exam and medical history. They will also

have blood and urine tests. An ultrasound with fluid of the uterus will test for fibroids. Uterine cells will be collected for biopsy.

- For the next three menstrual cycles, participants will take either CDB-2914 or a

placebo. Treatment will be studied with blood tests and symptom diaries.

- At the end of the treatment, participants have three options. They can have surgery at

the Clinical Center or have another 3 months of CDB-2914. The third option is to stop treatment at the Clinical Center.

- Surgery will be either uterine ablation or hysterectomy. Only women older than age 33

may have a hysterectomy. Blood and urine samples will be collected after surgery.

- Both surgery and further treatment participants will have followup exams.

- All participants will have a final followup exam 1 year after stopping treatment.

Study to Evaluate the Safety and Efficacy of Two Contraceptive Vaginal Rings Delivering a Daily Dose of 1500 or 2500 μg of CDB-2914 [Recruiting]

Safety, Tolerability, and Efficacy of ellaOne® (Ulipristal Acetate) for Emergency Contraception in Postmenarcheal Adolescent Girls and Women [Recruiting]
The purpose of this observational study is to assess the safety and tolerability of ellaOne® in routine conditions of use for emergency contraception in postmenarcheal adolescents and adult women who want to prevent pregnancy up to 5 days after unprotected sexual intercourse.

Biodegradable Stents in Lung Transplantation [Recruiting]
A prospective observational trial involving 10 patients is planned. Intervention "SX-ELLA Stent Degradable DV Bronchial (DV Stent)" will be implanted in the target lesion in general anesthesia under fluoroscopy or by direct vision. Before dilatation, extension of the airway complications will be measured by bronchoscopy and documented.

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Reports of Suspected Ella (Ulipristal) Side Effects

Unintended Pregnancy (4),  Maternal Exposure During Pregnancy (3),  Drug Ineffective (2),  Thirst (2),  DRY Mouth (2),  Drug Prescribing Error (2),  Drug Interaction (1),  Pregnancy After Post Coital Contraception (1),  Menstrual Disorder (1),  Menstruation Irregular (1), more >>