Contraceptive Efficacy, Tolerance and Acceptability of a Benzalkonium Chloride Spermicide Cream In Women Aged Over 40 Years of Age
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 151
- 试验地点
- 8
- 主要终点
- Contraceptive Efficacy- PI over up to 12 months - typical use
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Women ≥ 40 years of age, fertile, having had at least one menstrual cycle in the course of the last three months
- •Women who were informed about the risks and benefits of all contraceptive methods, and for whom contraceptive methods other than spermicides were not suitable
- •Women who need a contraceptive method and who accept to use a spermicide for at least 6 months.
- •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)).))
- •Women who accept to comply with the requirements of the protocol including visits assessments and diary completion after each sexual intercourse
- •Women who have had a normal smear test < 3 years
- •Women affiliated to a public health insurance coverage
- •Women who have read, understood, dated and signed the informed consent form
排除标准
- •Women who are not able to understand a birth control method with Pharmatex® cream
- •Women who have had an unprotected sexual intercourse within 7 days before the Baseline Visit
- •Allergy or hypersensitivity to one of the components of Pharmatex® cream
- •Medical contraindication to pregnancy
- •Abnormal results of cervico-vaginal and/or vulvo-vaginal clinical examination (e.g. severe atrophic vaginitis etc.)
- •Women with history of > 2 induced abortions during lifetime (miscarriages and spontaneous abortions are not included)
- •Women with history of infectious vaginitis within the last 6 months
- •Women treated for STI within the last three months
- •HIV positive women and high-risk women for HIV
- •Breastfeeding women
- •Women participating or having participated in a clinical trial within four weeks prior to inclusion
- •Women deprived of liberty by a legal or administrative decision
研究组 & 干预措施
Benzalkonium Chloride Spermicide Cream
Pharmatex 1,2% vaginal cream (benzalkonium chloride 1,2g per 100g of vaginal cream)
干预措施: Benzalkonium Chloride Spermicide Cream (Drug)
结局指标
主要结局
Contraceptive Efficacy- PI over up to 12 months - typical use
时间窗: up to 12 months after the inclusion
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)
次要结局
- Contraceptive Efficacy - Pregnancy rate over up to 12 months - typical use(up to 12 months after the inclusion)
- Contraceptive Efficacy - Pregnancy rate over up to 12 months - perfect use(up to 12 months after the inclusion)
- Contraceptive Efficacy - PI over up to 6 months - typical use(up to 6 months after the inclusion)
- Contraceptive Efficacy - PI over up to 6 months - perfect use(up to 6 months after the inclusion)
- Contraceptive Efficacy - Pregnancy rate over up to 6 months - typical use(up to 6 months after the inclusion)
- Contraceptive Efficacy - Pregnancy rate over up to 6 months - perfect use(up to 6 months after the inclusion)
- Acceptability - global satisfaction of the investigator (Likert scale)(2, 6, 12 months after the inclusion)
- Contraceptive Efficacy - PI over up to 12 months - perfect use(up to 12 months after the inclusion)
- Number of adverse events(6 or 12 months after the inclusion)
- Percentage of adverse events(6 or 12 months after the inclusion)
- Acceptability - percentage of continuation(up to 6 or 12 months after the inclusion)
- Acceptability - adherence(up to 6 or 12 months after the inclusion)
- Acceptability - ease of use (Likert scale)(up to 6 or 12 months after the inclusion)
- Acceptability - lubricating effect (Likert scale)(up to 6 or 12 months after the inclusion)
- Acceptability - global satisfaction of the woman (Likert scale)(1, 2, 4, 6, 9, 12 months after the inclusion)