Polidocanol Foam
- User: Female
- Hormonal: Non-Hormonal
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Delivery type:
- Fallopian Tube
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Intended Duration:
- Permanent
- Development Stage: Pre-Clinical
- Developer(s)/researcher(s): Oregon Health & Science University
Details
- API: Polidocanol
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Mechanism of Action:
- Tubal Occlusion
- Inactive Materials: Not Yet Determined
- Regimen: Single Administration
- MPT: Not Potential MPT
- Promising Attributes: Non-surgical sterilization. A smaller quantity of material may be able to be injected due to the foam's ability to expand. Tubal occlusion is confined to the intramural portion of the fallopian tube, potentially improving recovery and efficacy.
Product Status
Results from polidocanol/doxycycline foam study in baboons were disseminated by the OHSU research team as recently as 2020, and developer has confirmed through CTI Exchange solicitation that development of a polidocanol-only formulation is active. No indication of IND application/approval or human studies.
History
2010: Polidocanol solutions receive FDA approval as a sclerosing therapy for varicose veins. Approval is followed by evaluation of polidocanol when administered as a foam.
2014: OHSU researchers determine that 5% polidocanol foam produces bilateral tubal occlusion in macaques, indicating its strong potential as a method of permanent sterilization.
2016: OHSU researchers determine that 5% polidocanol foam produces tubal occlusion in baboons within 1-2 months. Efficacy is impacted by combination with doxycycline or benzalkonium chloride. Researchers conclude that additional evaluation is needed to produce efficacy near 100% following one administration of foam.
2020: An 18 month baboon study indicates that the combination of palidocanol and doxycycline produces reasonably consistent bilateral tubal occlusion + pelvic adhesions (likely linked to the addition of doxycycline, an anti-bacterial treatment). 2 out of 12 baboons experience only unilateral occlusion and become pregnant.
2025: Developer confirms to CTI Exchange that doxycycline has been removed from formulation due to its association with an increase in adverse events with no increase in efficacy. Development of polidocanol-only product using a selective catheter remains active.