Daily Oral Ulipristal Acetate
ROC
- User: Female
- Hormonal: Hormonal
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Delivery type:
- Oral
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Intended Duration:
- Short-Acting
- Development Stage: Phase II
- Developer(s)/researcher(s): Contraceptive Clinical Trials Network, NICHD, HRA Pharma
Details
- API: Ulipristal Acetate
- Target: Progesterone Receptor
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Mechanism of Action:
- Ovulation Inhibition
- Regimen: Not Yet Determined
- MPT: Not Potential MPT
- Promising Attributes: Ulipristal Acetate has regulatory approval as an emergency contraceptive. It may present a more desirable side effect profile than commercially-available oral contraceptives.
Product Status
Active/Recent Clinical Development
History
2009-2010: Ulipristal Acetate receives European and US regulatory approval as an emergency contraceptive, taken immediately following sex to delay ovulation
2012: UPA receives approval for use as a treatment of uterine fibroids
2014 - Present: UPA is evaluated as the primary API in novel contraceptive vaginal rings, alone and in combination with other drugs or copper
2022: Results from a Phase I/II trial indicate that daily oral UPA does produce dose-dependent inhibition of ovulation and endometrial changes, but that ovulation was not fully suppressed by any of the evaluated doses/regimens. Researchers recommended further evaluation to determine whether the chemical ovulations documented during the trial were functional ovulations (meaning an egg was released into the fallopian tube) or whether they reflect only a change in progesterone levels without actual release of an egg.
2025: Reproductive researchers publish commentary advocating for a renewal of evaluation of UPA for new therapeutic and preventative indications, including use as a contraceptive. The commentary notes that evaluation was partially stalled due to concerns regarding liver toxicity, but that UPA's role in liver injury had not been confirmed.