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

Last updated: February 25, 2020
Sponsor: Laboratoire Innotech International
Overall Status: Completed

Phase

4

Condition

Contraception

Treatment

N/A

Clinical Study ID

NCT03102450
PHX 401-14
  • Ages > 40
  • Female

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Women ≥ 40 years of age, fertile, having had at least one menstrual cycle in thecourse of the last three months

  2. Women who were informed about the risks and benefits of all contraceptive methods, andfor 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 testshould be performed at investigator's office then confirmed by a blood test performedin a local laboratory (quantitative beta hCG dosage)).))

  5. Women who accept to comply with the requirements of the protocol including visitsassessments 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

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 BaselineVisit

  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 andspontaneous 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 priorto inclusion

  12. Women deprived of liberty by a legal or administrative decision

Study Design

Total Participants: 151
Study Start date:
December 26, 2017
Estimated Completion Date:
October 17, 2019

Study 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.

Connect with a study center

  • Cabinet Gynecologie

    Carnoux-en-Provence, 13470
    France

    Site Not Available

  • Cabinet Gynecologie

    Lyon, 69009
    France

    Site Not Available

  • Cabinet de Gynecologie

    Lyon, 69009
    France

    Site Not Available

  • Cabinet de Gynecologie

    Marseille, 13008
    France

    Site Not Available

  • Cabinet de Gynecologie

    Nantes, 44000
    France

    Site Not Available

  • Cabinet Gynecologie

    Neuilly-sur-Seine, 92200
    France

    Site Not Available

  • Cabinet Gynecologie

    Orléans, 45100
    France

    Site Not Available

  • Cabinet Gynecologie

    Paris, 75016
    France

    Site Not Available

  • Cabinet Gynecologique

    Strasbourg, 67000
    France

    Site Not Available

  • Cabinet de Gynecologie

    Écully, 69130
    France

    Site Not Available

  • "The Pirogov Russian National Research Medical University"

    Moscow,
    Russian Federation

    Site Not Available

  • A.I. Yevdokimov Moscow State University of Medicine and Dentistry"

    Moscow,
    Russian Federation

    Site Not Available

  • Closed Joint-Stock Company "Heirs"/Nasledniki Ltd.

    Moscow, 119192
    Russian Federation

    Site Not Available

  • FSBI "Scientific Center of Obstetrics, Gynecology and Perinatology n.a. V.I. Kulakov"

    Moscow,
    Russian Federation

    Site Not Available

  • I.M. Sechenov First Moscow State Medical University"

    Moscow,
    Russian Federation

    Site Not Available

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