Contraceptive Efficacy, Tolerance and Acceptability of A Benzalkonium Chloride Spermicide Cream In Women Aged Over 40 Years of Age
- Conditions
- The current study is conducted in adult women over 40 years of age who need a contraceptive method and who accept to use a spermicide, according to the following inclusion/exclusion criteria and after the signature of the informed consent form.Only outpatients (women) are included in the study.MedDRA version: 19.1Level: PTClassification code 10067045Term: Chemical contraceptionSystem Organ Class: 10042613 - Surgical and medical proceduresTherapeutic area: Body processes [G] - Chemical Phenomena [G02]
- Registration Number
- EUCTR2016-004188-38-FR
- Lead Sponsor
- ABORATOIRE INNOTECH INTERNATIONA
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 150
1. Women = 40 years of age, fertile, having had at least one menstrual cycle in the course of the last three months
2. Women who need a contraceptive method and who accept to use a spermicide for at least 6 months
3. Women who have a negative pregnancy test at inclusion (the urinary pregnancy test should be performed at investigator’s office then confirmed by a blood test performed in a local laboratory (quantitative beta hCG dosage))
4. Women who accept to comply with the requirements of the protocol including visits assessments and diary completion after each sexual intercourse
5. Women who have had a normal smear test < 3 years
6. Women affiliated to a public health insurance coverage
7. Women who have read, understood, dated and signed the informed consent form
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 150
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
1. Women who are not able to understand a birth control method with Pharmatex® cream
2. Women who have had an unprotected sexual intercourse within 7 days before the Baseline Visit
3. Allergy or hypersensitivity to one of the components of Pharmatex® cream
4. Medical contraindication to pregnancy
5. Abnormal results of cervico-vaginal and/or vulvo-vaginal clinical examination (e.g. severe atrophic vaginitis etc.)
6. Women with history of > 2 induced abortions during lifetime (miscarriages and spontaneous abortions are not included)
7. Women with history of infectious vaginitis within the last 6 months
8. Women treated for STI within the last three months
9. HIV positive women and high-risk women for HIV
10. Breastfeeding women
11. Women participating or having participated in a clinical trial within four weeks prior to inclusion
12. Women deprived of liberty by a legal or administrative decision
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method