Document Detail

Study of the intravaginal insert (IVI): acceptability, side effects, and post-coital spermicidal activity.
MedLine Citation:
PMID:  6099026     Owner:  NLM     Status:  MEDLINE    
The authors describe their experience with a group of 49 sexually active, already protected women in order to evaluate the acceptability, side effects and post-coital spermicidal activity of a new vaginal contraceptive. The intravaginal insert (IVI) consists of a polyester resin plug (sponge) containing a 5% solution of nonoxynol-9 bound in a cold formation process, and having a cotton loop attached to the lower end. The results of this study indicate that this new vaginal contraceptive is free of major side effects, is well accepted by users, and has strong spermicidal and mechanical activity. Future clinical testing in order to try its anti-conceptive effectiveness is warranted.
To determine the safety, acceptability, and spermicidal effect of a new female barrier contraceptive sponge -- the intravaginal insert (IVI), 49 women, 18-35 years, who attended family planning clinics at the University of Texas Health Science Center at San Antonio and who were either IUD users or had had bilateral tubal sterilization at least 6 months earlier, were studied. The women had experienced regular menstrual cycles during the previous 3 months, had a normal reproductive history, and normal physical and pelvic examinations, including pap smear and gonorrhea culture, and were sexually active. Participants were active in the study for 6 weeks. Intravaginal inserts were used for a total of 30 days. Participants made at least 4 clinic visits during the study, and those who showed signs of irritation or had other complaints made additional visits as needed. During the initial visit, participants were instructed in the use of the IVI and were randomly assigned to 1 of 4 groups according to the frequency with which the IVI was changed. The IVI consists of a polyester resin plug containing a 5% solution of the spermicidal surfactant, nonoxynol-9 (N-9) bound in a cold formation process, with a cotton string loop attached to the lower end. The sponge is introduced into the vagina with a syringe-like applicator. Women assigned to the daily group (Group 1, n = 16) were to leave the inserts in place for 24 hours; those in the 2-day group (Group 2, n = 12) were to leave the insert in place for 48 hours; those in the 3-day group (Group 3, n = 16) were to leave the insert in place for 72 hours. The women in Groups 1, 2, and 3 were then to report to the clinic 1, 2, and 3 days after study admission, respectively, for their 1st follow-up visit. A control group (Group 4, n = 5) was given a non-medicated IVI, and followed the same protocol as group 3. All women returned to the clinic after 30 days of use. 2 weeks later, a final visit was scheduled. Previous contraceptive practice indicated that 42 women (85.7%) had prior experience with female barrier methods, with 31 (63%) having 6 months or more of extensive use of some type of female barrier contraceptive. 13 cases were classified as Class I -- negative with signs of inflammation. 2 cases were classified as Class II, showing minimal dysplasia associated with trichomoniasis; these patients were treated with a 7-day regimen of metronidazole and their repeat pap smears were normal. These 15 cases of abnormal pap smears were divided among the 4 groups as follows: Group 1, 3; Group 2, 4; Group 3, 6; and Group 4 (controls), 2. Women in the 72-hour group always complained of some degree of foul smell, which was detected by the investigator during the follow-up visits when the IVIs were removed. Results of the postcoital test suggest that the IVI works as a contraceptive by 2 mechanisms -- mechanical and chemical. The longer the period of use, the less residual N-9 concentration was detected in the sponge, showing the effective, slow, constant release of N-9 over time. This new vaginal contraceptive is free of major side effects.
M Ahmad; R H Asch
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Publication Detail:
Type:  Clinical Trial; Journal Article; Research Support, Non-U.S. Gov't; Research Support, U.S. Gov't, Non-P.H.S.    
Journal Detail:
Title:  Acta Europaea fertilitatis     Volume:  15     ISSN:  0587-2421     ISO Abbreviation:  Acta Eur. Fertil.     Publication Date:    1984 Sep-Oct
Date Detail:
Created Date:  1985-04-17     Completed Date:  1985-04-17     Revised Date:  2007-11-15    
Medline Journal Info:
Nlm Unique ID:  1300660     Medline TA:  Acta Eur Fertil     Country:  ITALY    
Other Details:
Languages:  eng     Pagination:  369-76     Citation Subset:  IM; J    
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MeSH Terms
Clinical Trials as Topic
Contraceptive Devices, Female* / adverse effects
Polyethylene Glycols* / adverse effects
Random Allocation
Resins, Synthetic
Socioeconomic Factors
Spermatocidal Agents* / adverse effects
Time Factors
Reg. No./Substance:
0/Polyethylene Glycols; 0/Resins, Synthetic; 0/Spermatocidal Agents; 26027-38-3/Nonoxynol

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine

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