A Phase 4 interventional study of Benzalkonium Chloride Spermicide Cream in Contraception, sponsored by Laboratoire Innotech International. Completed at 15 sites in 2 countries. Open to female participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2020-02-26.
Sponsored by Laboratoire Innotech International · Phase 4, Interventional, and Treatment
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.
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.
Laboratoire Innotech International is the lead sponsor of 5 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Pharmatex 1,2% vaginal cream (benzalkonium chloride 1,2g per 100g of vaginal cream)
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)
Also known as: Pharmatex 1,2% vaginal cream
Contraceptive Efficacy- PI over up to 12 months - typical use
Contraceptive efficacy of Pharmatex® cream expressed by the Pearl Index (PI) over up to 12 months of typical use. The Pearl Index is defined as the number of unintended pregnancies per 100 woman-years of a contraceptive method's use * Success: no fertilisation * Failure: unintended fertilisation (pregnancy or aborted pregnancy)
Time frame: up to 12 months after the inclusion
Contraceptive Efficacy - PI over up to 12 months - perfect use
Contraceptive efficacy of Pharmatex® cream expressed by the Pearl Index (PI) over up to 12 months of perfect use
Time frame: up to 12 months after the inclusion
Contraceptive Efficacy - PI over up to 6 months - typical use
Contraceptive efficacy of Pharmatex® cream expressed by the Pearl Index (PI) at Visit 3 (M6) over up to 6 months of typical use
Time frame: up to 6 months after the inclusion
Contraceptive Efficacy - PI over up to 6 months - perfect use
Contraceptive efficacy of Pharmatex® cream expressed by the Pearl Index (PI) at Visit 3 (M6) over up to 6 months of perfect use
Time frame: up to 6 months after the inclusion
Contraceptive Efficacy - Pregnancy rate over up to 6 months - typical use
Contraceptive efficacy of Pharmatex® cream expressed by the rate of pregnancy over up to 6 months of typical use at Visit 3 (M6)
Time frame: up to 6 months after the inclusion
Contraceptive Efficacy - Pregnancy rate over up to 6 months - perfect use
Contraceptive efficacy of Pharmatex® cream expressed by the rate of pregnancy over up to 6 months of perfect use at Visit 3 (M6)
Time frame: up to 6 months after the inclusion
Contraceptive Efficacy - Pregnancy rate over up to 12 months - typical use
Contraceptive efficacy of Pharmatex® cream expressed by the rate of pregnancy over up to 12 months of typical use at Visit 4 (M12)
Time frame: up to 12 months after the inclusion
Contraceptive Efficacy - Pregnancy rate over up to 12 months - perfect use
Contraceptive efficacy of Pharmatex® cream expressed by the rate of pregnancy over up to 12 months of perfect use at Visit 4 (M12)
Time frame: up to 12 months after the inclusion
Number of adverse events
Number of adverse events during the study
Time frame: 6 or 12 months after the inclusion
Percentage of adverse events
Percentage of adverse events during the study
Time frame: 6 or 12 months after the inclusion
Acceptability - percentage of continuation
Evaluation of the acceptability of the treatment by percentage of continuation until the end of follow-up (at 6 months for all the women and at 12 months for women who have accepted to continue at visit 3 (M6))
Time frame: up to 6 or 12 months after the inclusion
Acceptability - adherence
Evaluation of the acceptability of the treatment through adherence: systematic use of benzalkonium chloride spermicide before each event of sexual intercourse recorded in the self-evaluation diary
Time frame: up to 6 or 12 months after the inclusion
Acceptability - ease of use (Likert scale)
Evaluation of the acceptability of the treatment (ease of use) evaluated through the self-evaluation diary (Likert scale) up to M6 (V3) and up to M12 (V4) for women who have continued for 12 months
Time frame: up to 6 or 12 months after the inclusion
Acceptability - lubricating effect (Likert scale)
Evaluation of the acceptability of the treatment through the lubricating effect (Likert scale) at the end of study visit: V3 (M6), or V4 (M12) or at intermediate visit in case of early withdrawal
Time frame: up to 6 or 12 months after the inclusion
Acceptability - global satisfaction of the woman (Likert scale)
Evaluation of the global satisfaction of the treatment (Likert scale) by the woman at V2 (M2), V3 (M6) and V4 (M12) and during phone contacts PC1 (M1), PC2 (M4) and PC3 (M9)
Time frame: 1, 2, 4, 6, 9, 12 months after the inclusion
Acceptability - global satisfaction of the investigator (Likert scale)
Evaluation of the global satisfaction of the treatment (Likert scale) by the investigator at V2 (M2), V3 (M6) and V4 (M12).
Time frame: 2, 6, 12 months after the inclusion
Plan to share: No
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Laboratoire Innotech International