Contraceptive Efficacy, Tolerance and Acceptability of a Benzalkonium Chloride Spermicide Cream In Women Aged Over 40 Years of Age

• Status: Completed
• Trial end date: 2019-10-17
• Target enrollment: 0
• Participant gender: Female

Summary

In spite of many advantages of spermicides, there is no contraceptive efficacy study conducted with any spermicide in women aged over 40 years. That is why the aim of this study is to evaluate contraceptive efficacy, tolerance and acceptability of a spermicide with benzalkonium chloride (Pharmatex® cream) in women aged over 40 years.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Laboratoire Innotech International
• Collaborator: ITEC Services
• Treatments: Benzalkonium Compounds

Criteria

Inclusion Criteria:

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 were informed about the risks and benefits of all contraceptive methods, and for whom contraceptive methods other than spermicides were not suitable

3. Women who need a contraceptive method and who accept to use a spermicide for at least 6 months.

4. 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)).))

5. Women who accept to comply with the requirements of the protocol including visits assessments and diary completion after each sexual intercourse

6. Women who have had a normal smear test < 3 years

7. Women affiliated to a public health insurance coverage

8. Women who have read, understood, dated and signed the informed consent form

Exclusion Criteria:

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