A multinational evaluation of the efficacy, safety and acceptability of the Protectaid contraceptive sponge
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Published on: September 10, 2018
G Creatsas1, E Guerrero, E Guilbert
1University of Athens, Areteion Maternity Hospital, Greece.
Objective:
The Protectaid sponge (Gefar Pharma, Switzerland) is a new feminine barrier contraceptive method containing three low-dose spermicidal agents. In order to evaluate its efficacy and safety profiles, an international, multicenter study has been conducted in four countries.
Methods:
Healthy, presumably fertile and sexually active women were enrolled in this study and were followed at 15 days, 3, 6, 9 and 12 months. Contraceptive efficacy was assessed by a pregnancy test, while safety was evaluated by performing gynecological examinations as well as reporting adverse events. The 'acceptability' of the sponge by the women was assessed through a standard questionnaire.
Results:
A total of 129 women were enrolled in the study, generating 1182 cycles of use of the sponge. The overall efficacy rate was 77%, with no significant influence of age or parity. Acceptability was high, with 85% of subjects being symptom- or problem-free while using the sponge. Finally, the safety profile was very good, with no clinically significant evidence of local or systemic adverse reactions.
Conclusion:
The new Protectaid sponge is a safe and effective non-hormonal contraceptive method for women.
