Effectiveness of BenZalKonium chloride gel as vaginal contraceptive: a multicentric randomised controlled trial
| ISRCTN | ISRCTN16203579 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN16203579 |
| ClinicalTrials.gov number | NCT00692952 |
| Secondary identifying numbers | Chinese State Food And Drug Administration, Clinical Trial Permission No. 2003L02778 |
- 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
Not provided at time of registration
Contact information
Prof Xuncheng Ding
Scientific
Scientific
Shanghai Institute of Planned Parenthood Resarch
2140 Xie Tu Road
Shanghai
200032
China
Study information
| Study design | Phase II multicentric randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Scientific title | Effectiveness of BenZalKonium chloride gel as vaginal contraceptive: a randomised controlled trial among Chinese women |
| Study 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(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. |
| 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 |
| Pharmaceutical study type(s) | |
| Phase | Phase II |
| Drug / device / biological / vaccine name(s) | Benzalkonium chloride (BZK), nonoxynol-9 (Lelemi®) |
| Primary outcome measure | 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 study start date | 01/03/2004 |
| Overall study end date | 01/11/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Female |
| Target number of participants | 200 |
| 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 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
Study participating centre
Shanghai Institute of Planned Parenthood Resarch
Shanghai
200032
China
200032
China
Sponsor information
Shanghai Institute of Planned Parenthood Research (China)
Research organisation
Research organisation
World Health Organization (WHO) Collaborating Centre for Research in Human Reproduction
2140 Xie Tu Road
Shanghai
200032
China
"ROR" |
https://ror.org/03awxj939 |
|---|
Funders
Funder type
Research organisation
Shanghai Institute of Planned Parenthood Research (China) - World Health Organization (WHO) Collaborating Centre for Research in Human Reproduction
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | 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
