Effectiveness of BenZalKonium chloride gel as vaginal contraceptive: a multicentric randomised controlled trial

ISRCTN	ISRCTN16203579
DOI	https://doi.org/10.1186/ISRCTN16203579
ClinicalTrials.gov (NCT)	NCT00692952
Protocol serial number	Chinese State Food And Drug Administration, Clinical Trial Permission No. 2003L02778
Sponsor	Shanghai Institute of Planned Parenthood Research (China)
Funder	Shanghai Institute of Planned Parenthood Research (China) - World Health Organization (WHO) Collaborating Centre for Research in Human Reproduction

Submission date: 19/05/2008
Registration date: 29/05/2008
Last edited: 28/01/2019

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Pregnancy and Childbirth

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

Not provided at time of registration

Contact information

Prof Xuncheng Ding
Scientific

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

Study information

Primary study design	Interventional
Study design	Phase II multicentric randomised controlled trial
Secondary study design	Randomised controlled trial
Scientific title	Effectiveness of BenZalKonium chloride gel as vaginal contraceptive: a randomised controlled trial among Chinese women
Study acronym	BZK contraceptive gel
Study objectives	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(s)	Ethics approval received from the Ethical Committee of International Peace Maternity and Child Care Centre, Shanghai (P.R. China) on the 5th March 2004.
Health condition(s) or problem(s) studied	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 / device / biological / vaccine name(s)	Benzalkonium chloride (BZK), nonoxynol-9 (Lelemi®)
Primary outcome measure(s)	Contraceptive effectiveness. Outcomes were assessed at 2, 4 and 6-month follow-up visits.
Key secondary outcome measure(s)	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.
Completion date	01/11/2005

Eligibility

Participant type(s)	Patient
Age group	Adult
Sex	Female
Target sample size at registration	200
Key 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
Key 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
Date of first enrolment	01/03/2004
Date of final enrolment	01/11/2005

Locations

Countries of recruitment

China

Study participating centre

Shanghai Institute of Planned Parenthood Resarch

Shanghai
200032
China

Results and Publications

Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not provided at time of registration
IPD sharing plan

Study outputs

Output type	Details	Date created	Date added	Peer reviewed?	Patient-facing?
Results article	results	01/06/2013	28/01/2019	Yes	No

Editorial Notes

28/01/2019: Publication reference added