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

Laboratoire Innotech International151 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

151

Conditions

Contraception

Interventions

Benzalkonium Chloride Spermicide CreamDRUG

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)

Eligibility

Sex: FEMALEMin age: 40 Years

Medical Language ↔ Plain English

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

Locations (15)

Cabinet Gynecologie

Carnoux-en-Provence, France

Cabinet de Gynecologie

Écully, France

Cabinet de Gynecologie

Lyon, France

Outcomes

Primary Outcomes

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

Secondary Outcomes

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)

Data from ClinicalTrials.gov

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