A multinational evaluation of the efficacy, safety and acceptability of the Protectaid contraceptive sponge.
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.


CONCLUSIONS
The new Protectaid sponge is a safe and effective non-hormonal contraceptive method for women.
Creatsas
G
G
University of Athens, Areteion Maternity Hospital, Greece.
Guerrero
E
E
Guilbert
E
E
Drouin
J
J
Serfaty
D
D
Lemieux
L
L
Suissa
S
S
Colin
P
P
D000282:Administration, Intravaginal; D000328:Adult; D001548:Benzalkonium Compounds / Q000008:administration & dosage / Q000009:adverse effects*; D002170:Canada; D003267:Contraception / Q000379:methods* / Q000523:psychology; D003268:Contraception Behavior / Q000523:psychology; D003274:Contraceptive Devices, Female; D004293:Dominican Republic; D005260:Female; D005602:France; D006115:Greece; D006801:Humans; D008597:Menstrual Cycle; D017137:Nonoxynol / Q000008:administration & dosage / Q000009:adverse effects*; D011140:Polyurethanes; D011247:Pregnancy; D018873:Pregnancy Rate; D020358:Sodium Cholate / Q000008:administration & dosage / Q000009:adverse effects*; D013089:Spermatocidal Agents / Q000008:administration & dosage*; D011795:Surveys and Questionnaires; D013997:Time Factors
D001548:Benzalkonium Compounds; D011140:Polyurethanes; C453301:Protectaid; D013089:Spermatocidal Agents; D017137:Nonoxynol; D020358:Sodium Cholate