Condition category
Pregnancy and Childbirth
Date applied
19/05/2008
Date assigned
29/05/2008
Last edited
01/12/2008
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Prof Xuncheng Ding

ORCID ID

Contact details

Shanghai Institute of Planned Parenthood Resarch
2140 Xie Tu Road
Shanghai
200032
China

Additional identifiers

EudraCT number

ClinicalTrials.gov number

NCT00692952

Protocol/serial number

Chinese State Food And Drug Administration, Clinical Trial Permission No. 2003L02778

Study information

Scientific title

Effectiveness of BenZalKonium chloride gel as vaginal contraceptive: a randomised controlled trial among Chinese women

Acronym

BZK contraceptive gel

Study hypothesis

A multicentric clinical trial in three Chinese Maternal and Child Hospitals was conducted to evaluate the efficacy, safety and acceptability of a newly-developed vaginal contraceptive gel, the optimised benzalkonium chloride (BZK) gel containing 18 mg BZK, with comparison to a currently marketed (in China) contraceptive gel Lelemi® containing 50 mg Nonoxynol-9 (N-9).

Ethics approval

Ethics approval received from the Ethical Committee of International Peace Maternity and Child Care Centre, Shanghai (P.R. China) on the 5th March 2004.

Study design

Phase II multicentric randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Contraceptive effectiveness

Intervention

Participants received either benzalkonium chloride gel or nonoxynol-9 gel as their primary method of contraception. All treatment arms were followed for six months.

The test drug, Benzakonium Chloride Contraceptive Gel (Brand name: Konrapo spermicide gel), was provided by Shanghai Institute of Planned Parenthood Research and Changjiang Bio-pharmaceutical Co. Ltd. 4.2 ml 0.429% BZK gel is filled in a disposable applicator for single use (18 mg BZK per piece), Lot No. 20040108. The gel is ready to use and should be inserted into vagina before every coital act. The drug action lasts for 24 hours, however, it is recommended to finish the coital act within 4 hours.

The control drug, Nonoxyno-9 Contraceptive Gel (Lelemi® Contraceptive Gel), was provided by Pharmaceutical Co. Ltd, Chinese Pharmaceutical University. Each piece of gel contains 50 mg N-9. The gel should be inserted into vagina within half an hour before each sexual intercourse. After the insertion, women are not allowed to walk and the sexual intercourse should be finished within half an hour. Otherwise, another piece should be inserted.

Intervention type

Drug

Phase

Phase II

Drug names

Benzalkonium chloride (BZK), nonoxynol-9 (Lelemi®)

Primary outcome measures

Contraceptive effectiveness. Outcomes were assessed at 2, 4 and 6-month follow-up visits.

Secondary outcome measures

1. Safety, evaluated based on gynaecological examination, cytobacteriological examinations, blood test, urine test, reporting adverse events, and termination due to medical reasons. An adverse event was a change in health status from that at baseline, regardless of its possible relationship with the product, consistent with good clinical practice guidelines.
2. Product acceptability, assessed through a standard questionnaire

Outcomes were assessed at 2, 4 and 6-month follow-up visits.

Overall trial start date

01/03/2004

Overall trial end date

01/11/2005

Reason abandoned

Eligibility

Participant inclusion criteria

Eligibility requirements included:
1. Sexually active female
2. Aged 20 - 45 years old
3. Presumably fertile based on at least one delivery record
4. At risk for pregnancy and desiring contraception
5. Having regular menstrual cycle (21 - 35 days) and at least three normal menstrual cycles since the last pregnancy, abortion or hormone contraceptive use
6. Be willing to engage in at least four acts of sexual intercourse per month
7. Use the test products as their primary method of contraception
8. Keep a diary of coital activity, product use, and adverse events
9. At low risk for human immunodeficiency virus (HIV) or other sexually transmitted infection, which was defined as having a single sexual partner (for at least six months prior to study initiation)
10. The subject's sexual partner should not be presumably infertile, have a known allergy to BZK or N-9, or have been treated for sexually transmitted diseases (STDs) within six months prior to study entry

Participant type

Patient

Age group

Adult

Gender

Female

Target number of participants

200

Participant exclusion criteria

Exclusion criteria included:
1. Diagnosis of any vaginal infection or any symptom of STDs at baseline
2. Known allergy or hypersensitivity to N-9 or BZK
3. Menopause for more than one month
4. Breastfeeding
5. Vaginal bleeding with unknown reasons
6. Recurrent vaginitis or urinary infection
7. Genitourinary system anomaly
8. Hysteroptosis II or severe cystocele
9. Moderate to severe erosion of cervix
10. Malignant reproductive system tumours

Recruitment start date

01/03/2004

Recruitment end date

01/11/2005

Locations

Countries of recruitment

China

Trial participating centre

Shanghai Institute of Planned Parenthood Resarch
Shanghai
200032
China

Sponsor information

Organisation

Shanghai Institute of Planned Parenthood Research (China)

Sponsor details

World Health Organization (WHO) Collaborating Centre for Research in Human Reproduction
2140 Xie Tu Road
Shanghai
200032
China

Sponsor type

Research organisation

Website

Funders

Funder type

Research organisation

Funder name

Shanghai Institute of Planned Parenthood Research (China) - World Health Organization (WHO) Collaborating Centre for Research in Human Reproduction

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes