Clinical trial NCT03102450: Contraceptive Efficacy, Tolerance and Acceptability of a Benzalkonium Chloride Spermicide Cream In Women Aged Over 40 Years of Age
Official title: Contraceptive Efficacy, Tolerance and Acceptability of a Benzalkonium Chloride Spermicide Cream In Women Aged Over 40 Years of Age
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Contraception
Lead sponsor: Laboratoire Innotech International
Sponsor class: INDUSTRY
Collaborators: name: ITEC Services
First posted: 2017-04-05
Enrollment: 151
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Eligibility 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

Primary outcomes:
measure: Contraceptive Efficacy- PI over up to 12 months - typical use
timeFrame: up to 12 months after the inclusion
Secondary outcomes:
measure: Contraceptive Efficacy - PI over up to 12 months - perfect use
timeFrame: up to 12 months after the inclusion
measure: Contraceptive Efficacy - PI over up to 6 months - typical use
timeFrame: up to 6 months after the inclusion
measure: Contraceptive Efficacy - PI over up to 6 months - perfect use
timeFrame: up to 6 months after the inclusion
measure: Contraceptive Efficacy - Pregnancy rate over up to 6 months - typical use
timeFrame: up to 6 months after the inclusion
measure: Contraceptive Efficacy - Pregnancy rate over up to 6 months - perfect use
timeFrame: up to 6 months after the inclusion
measure: Contraceptive Efficacy - Pregnancy rate over up to 12 months - typical use
timeFrame: up to 12 months after the inclusion
measure: Contraceptive Efficacy - Pregnancy rate over up to 12 months - perfect use
timeFrame: up to 12 months after the inclusion
measure: Number of adverse events
timeFrame: 6 or 12 months after the inclusion
measure: Percentage of adverse events
timeFrame: 6 or 12 months after the inclusion
measure: Acceptability - percentage of continuation
timeFrame: up to 6 or 12 months after the inclusion
measure: Acceptability - adherence
timeFrame: up to 6 or 12 months after the inclusion
measure: Acceptability - ease of use (Likert scale)
timeFrame: up to 6 or 12 months after the inclusion
measure: Acceptability - lubricating effect (Likert scale)
timeFrame: up to 6 or 12 months after the inclusion
measure: Acceptability - global satisfaction of the woman (Likert scale)
timeFrame: 1, 2, 4, 6, 9, 12 months after the inclusion
measure: Acceptability - global satisfaction of the investigator (Likert scale)
timeFrame: 2, 6, 12 months after the inclusion
Other outcomes:
Locations:
city: Carnoux-en-Provence
country: France
facility: Cabinet Gynecologie
city: Lyon
country: France
facility: Cabinet de Gynecologie
city: Lyon
country: France
facility: Cabinet Gynecologie
city: Marseille
country: France
facility: Cabinet de Gynecologie
city: Nantes
country: France
facility: Cabinet de Gynecologie
city: Neuilly-sur-Seine
country: France
facility: Cabinet Gynecologie
city: Orléans
country: France
facility: Cabinet Gynecologie
city: Paris
country: France
facility: Cabinet Gynecologie
city: Strasbourg
country: France
facility: Cabinet Gynecologique
city: Écully
country: France
facility: Cabinet de Gynecologie
city: Moscow
country: Russian Federation
facility: Closed Joint-Stock Company "Heirs"/Nasledniki Ltd.
city: Moscow
country: Russian Federation
facility: "The Pirogov Russian National Research Medical University"
city: Moscow
country: Russian Federation
facility: A.I. Yevdokimov Moscow State University of Medicine and Dentistry"
city: Moscow
country: Russian Federation
facility: FSBI "Scientific Center of Obstetrics, Gynecology and Perinatology n.a. V.I. Kulakov"
city: Moscow
country: Russian Federation
facility: I.M. Sechenov First Moscow State Medical University"
Study officials:
affiliation: 9 rue Villersexel 75007 PARIS
name: David Serfaty, MD
role: PRINCIPAL_INVESTIGATOR
References: