Tags

Type your tag names separated by a space and hit enter

A randomized, double-blind, placebo-controlled safety and acceptability study of two Invisible Condom formulations in women from Cameroon.
Contraception. 2009 Nov; 80(5):484-92.C

Abstract

BACKGROUND

The objectives of this clinical trial were to evaluate the safety, tolerance and acceptability of two gel formulations of the Invisible Condom: (i) the polymer alone and (ii) the polymer-containing sodium lauryl sulfate (SLS) compared to placebo when applied intravaginally with our unique applicator in sexually abstinent and active woman volunteers.

STUDY DESIGN

A randomized, doubled-blind, placebo-controlled study in healthy women from Yaoundé, Cameroon. Two hundred sixty women were randomized into three gel arms: (a) gel alone, (b) gel plus SLS and (c) placebo gel. Thirty-seven sexually abstinent women applied gel intravaginally once a day for 14 days, while 75, 74 and 74 sexually active women applied gel intravaginally once, twice or three times daily for 14 days, respectively.

RESULTS

Retention rate was high at 85% and 221 women applied the two products and the placebo for a total of 6005 times. Nugent score, H(2)O(2)-producing lactobacilli and vaginal pH were stable throughout the study and were not affected by the study products. Colposcopy showed neither genital ulceration nor mucosal lesions. No study product-related serious adverse events were reported. The majority of reported adverse events were mild or moderate and largely similar in all 3 arms. Satisfaction questionnaire showed that the gel formulations and applicator were generally comfortable and acceptable.

CONCLUSION

The Invisible Condom formulations and applicator were found to be comfortable, well tolerated and acceptable when applied intravaginally once, twice or thrice daily for 14 days. Thus, expanded safety evaluation is warranted.

Authors+Show Affiliations

Laboratoire de Santé Hygiène Mobile, Ministry of Public Health and Faculty of Medicine and Biomedical Sciences, University of Yaoundé I, Yaoundé, Cameroon.No affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Clinical Trial
Journal Article
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

19835725

Citation

Mbopi-Keou, Francois-Xavier, et al. "A Randomized, Double-blind, Placebo-controlled Safety and Acceptability Study of Two Invisible Condom Formulations in Women From Cameroon." Contraception, vol. 80, no. 5, 2009, pp. 484-92.
Mbopi-Keou FX, Trottier S, Omar RF, et al. A randomized, double-blind, placebo-controlled safety and acceptability study of two Invisible Condom formulations in women from Cameroon. Contraception. 2009;80(5):484-92.
Mbopi-Keou, F. X., Trottier, S., Omar, R. F., Nkele, N. N., Fokoua, S., Mbu, E. R., Giguere, J. F., Domingo, M. C., Piret, J., Tsague, L., Zekeng, L., Mwatha, A., Mâsse, B., & Bergeron, M. G. (2009). A randomized, double-blind, placebo-controlled safety and acceptability study of two Invisible Condom formulations in women from Cameroon. Contraception, 80(5), 484-92. https://doi.org/10.1016/j.contraception.2009.03.020
Mbopi-Keou FX, et al. A Randomized, Double-blind, Placebo-controlled Safety and Acceptability Study of Two Invisible Condom Formulations in Women From Cameroon. Contraception. 2009;80(5):484-92. PubMed PMID: 19835725.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - A randomized, double-blind, placebo-controlled safety and acceptability study of two Invisible Condom formulations in women from Cameroon. AU - Mbopi-Keou,Francois-Xavier, AU - Trottier,Sylvie, AU - Omar,Rabeea F, AU - Nkele,Ngoh N, AU - Fokoua,Séraphin, AU - Mbu,Enow R, AU - Giguere,Jean-Francois, AU - Domingo,Marc-Christian, AU - Piret,Jocelyne, AU - Tsague,Landry, AU - Zekeng,Leopold, AU - Mwatha,Anthony, AU - Mâsse,Benoît, AU - Bergeron,Michel G, Y1 - 2009/05/23/ PY - 2008/10/30/received PY - 2009/03/05/revised PY - 2009/03/31/accepted PY - 2009/10/20/entrez PY - 2009/10/20/pubmed PY - 2010/2/23/medline SP - 484 EP - 92 JF - Contraception JO - Contraception VL - 80 IS - 5 N2 - BACKGROUND: The objectives of this clinical trial were to evaluate the safety, tolerance and acceptability of two gel formulations of the Invisible Condom: (i) the polymer alone and (ii) the polymer-containing sodium lauryl sulfate (SLS) compared to placebo when applied intravaginally with our unique applicator in sexually abstinent and active woman volunteers. STUDY DESIGN: A randomized, doubled-blind, placebo-controlled study in healthy women from Yaoundé, Cameroon. Two hundred sixty women were randomized into three gel arms: (a) gel alone, (b) gel plus SLS and (c) placebo gel. Thirty-seven sexually abstinent women applied gel intravaginally once a day for 14 days, while 75, 74 and 74 sexually active women applied gel intravaginally once, twice or three times daily for 14 days, respectively. RESULTS: Retention rate was high at 85% and 221 women applied the two products and the placebo for a total of 6005 times. Nugent score, H(2)O(2)-producing lactobacilli and vaginal pH were stable throughout the study and were not affected by the study products. Colposcopy showed neither genital ulceration nor mucosal lesions. No study product-related serious adverse events were reported. The majority of reported adverse events were mild or moderate and largely similar in all 3 arms. Satisfaction questionnaire showed that the gel formulations and applicator were generally comfortable and acceptable. CONCLUSION: The Invisible Condom formulations and applicator were found to be comfortable, well tolerated and acceptable when applied intravaginally once, twice or thrice daily for 14 days. Thus, expanded safety evaluation is warranted. SN - 1879-0518 UR - https://www.unboundmedicine.com/medline/citation/19835725/A_randomized_double_blind_placebo_controlled_safety_and_acceptability_study_of_two_Invisible_Condom_formulations_in_women_from_Cameroon_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0010-7824(09)00115-2 DB - PRIME DP - Unbound Medicine ER -