NCT03102450

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 151 (actual)
• Sponsor: Laboratoire Innotech International · Industry
• Sex: Female
• Age: 40 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Not all contraceptive methods are appropriate for all situations, and the most appropriate method of birth control depends on the woman's overall health, her age, the frequency of her sexual activity, her sexual partners, her desire to have children in the future, and personal or family history of certain diseases. A special interest should be paid to women aged over 40 years. Decreased fertility, increased cardiovascular risks and greater exposure to gynecological disorders during perimenopause have led to reassess the contraceptive methods in this age group. Official guidelines allow the use of any contraceptive method - including combined estrogen progestin contraceptives (COCs) - that it had been well tolerated previously. However, more frequent contraindications during perimenopause can lead women to switch to other methods, such as the intrauterine device, the progestin-only contraception or sterilization. In this context, local contraception with spermicides represents an attractive alternative for perimenopausal women. Being totally safe, particularly metabolically, the use of spermicides in this age group is not restricted by national and international guidelines except in HIV high risk women or women with HIV clinical disease. Furthermore, the lubricating effect of a galenic formulation of spermicides, such as cream, is particularly useful in cases of vaginal dryness, which is common in perimenopausal women. Lastly, spermicides may be used in combination with other local methods of contraception. Considering the contraindications to other contraceptives, particularly hormonal contraceptives, and the greater risks associated with these methods during perimenopause, spermicides could be an appropriate alternative for a large number of perimenopausal women. Today, 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.

Conditions

• Contraception

Interventions

Type	Name	Description
DRUG	Benzalkonium Chloride Spermicide Cream	One dose of Pharmatex vaginal cream (benzalkonium chloride) must be used systematically before each intercourse, regardless of the cycle period, even during menstrual periods. In case of repeated acts of intercourse, an additional dose of cream must be used before each new act. Duration of treatment : 6 months (12 months optional)

Timeline

• Start date: 2017-12-26
• Primary completion: 2019-10-17
• Completion: 2019-10-17
• First posted: 2017-04-05
• Last updated: 2020-02-26

Locations

15 sites across 2 countries: France, Russia