Contraceptive Efficacy, Tolerance and Acceptability of a Benzalkonium Chloride Spermicide Cream In Women Aged Over 40 Years of Age (BZK40+)

February 25, 2020 updated by: Laboratoire Innotech International
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
151

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Carnoux-en-Provence, France, 13470
        • Cabinet Gynecologie
      • Lyon, France, 69009
        • Cabinet de gynécologie
      • Lyon, France, 69009
        • Cabinet Gynecologie
      • Marseille, France, 13008
        • Cabinet de gynécologie
      • Nantes, France, 44000
        • Cabinet de gynécologie
      • Neuilly-sur-Seine, France, 92200
        • Cabinet Gynecologie
      • Orléans, France, 45100
        • Cabinet Gynecologie
      • Paris, France, 75016
        • Cabinet Gynecologie
      • Strasbourg, France, 67000
        • Cabinet Gynecologique
      • Écully, France, 69130
        • Cabinet de gynécologie
  • Russian Federation
      • Moscow, Russian Federation, 119192
        • Closed Joint-Stock Company "Heirs"/Nasledniki Ltd.
      • Moscow, Russian Federation
        • "The Pirogov Russian National Research Medical University"
      • Moscow, Russian Federation
        • A.I. Yevdokimov Moscow State University of Medicine and Dentistry"
      • Moscow, Russian Federation
        • FSBI "Scientific Center of Obstetrics, Gynecology and Perinatology n.a. V.I. Kulakov"
      • Moscow, Russian Federation
        • I.M. Sechenov First Moscow State Medical University"

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Benzalkonium Chloride Spermicide Cream
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)

Other Names:
  • Pharmatex 1,2% vaginal cream

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Contraceptive Efficacy- PI over up to 12 months - typical use
Time Frame: 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)
up to 12 months after the inclusion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Contraceptive Efficacy - PI over up to 12 months - perfect use
Time Frame: up to 12 months after the inclusion
Contraceptive efficacy of Pharmatex® cream expressed by the Pearl Index (PI) over up to 12 months of perfect use
up to 12 months after the inclusion
Contraceptive Efficacy - PI over up to 6 months - typical use
Time Frame: up to 6 months after the inclusion
Contraceptive efficacy of Pharmatex® cream expressed by the Pearl Index (PI) at Visit 3 (M6) over up to 6 months of typical use
up to 6 months after the inclusion
Contraceptive Efficacy - PI over up to 6 months - perfect use
Time Frame: up to 6 months after the inclusion
Contraceptive efficacy of Pharmatex® cream expressed by the Pearl Index (PI) at Visit 3 (M6) over up to 6 months of perfect use
up to 6 months after the inclusion
Contraceptive Efficacy - Pregnancy rate over up to 6 months - typical use
Time Frame: up to 6 months after the inclusion
Contraceptive efficacy of Pharmatex® cream expressed by the rate of pregnancy over up to 6 months of typical use at Visit 3 (M6)
up to 6 months after the inclusion
Contraceptive Efficacy - Pregnancy rate over up to 6 months - perfect use
Time Frame: up to 6 months after the inclusion
Contraceptive efficacy of Pharmatex® cream expressed by the rate of pregnancy over up to 6 months of perfect use at Visit 3 (M6)
up to 6 months after the inclusion
Contraceptive Efficacy - Pregnancy rate over up to 12 months - typical use
Time Frame: up to 12 months after the inclusion
Contraceptive efficacy of Pharmatex® cream expressed by the rate of pregnancy over up to 12 months of typical use at Visit 4 (M12)
up to 12 months after the inclusion
Contraceptive Efficacy - Pregnancy rate over up to 12 months - perfect use
Time Frame: up to 12 months after the inclusion
Contraceptive efficacy of Pharmatex® cream expressed by the rate of pregnancy over up to 12 months of perfect use at Visit 4 (M12)
up to 12 months after the inclusion
Number of adverse events
Time Frame: 6 or 12 months after the inclusion
Number of adverse events during the study
6 or 12 months after the inclusion
Percentage of adverse events
Time Frame: 6 or 12 months after the inclusion
Percentage of adverse events during the study
6 or 12 months after the inclusion
Acceptability - percentage of continuation
Time Frame: up to 6 or 12 months after the inclusion
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))
up to 6 or 12 months after the inclusion
Acceptability - adherence
Time Frame: up to 6 or 12 months after the inclusion
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
up to 6 or 12 months after the inclusion
Acceptability - ease of use (Likert scale)
Time Frame: up to 6 or 12 months after the inclusion
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
up to 6 or 12 months after the inclusion
Acceptability - lubricating effect (Likert scale)
Time Frame: up to 6 or 12 months after the inclusion
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
up to 6 or 12 months after the inclusion
Acceptability - global satisfaction of the woman (Likert scale)
Time Frame: 1, 2, 4, 6, 9, 12 months after the inclusion
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)
1, 2, 4, 6, 9, 12 months after the inclusion
Acceptability - global satisfaction of the investigator (Likert scale)
Time Frame: 2, 6, 12 months after the inclusion
Evaluation of the global satisfaction of the treatment (Likert scale) by the investigator at V2 (M2), V3 (M6) and V4 (M12).
2, 6, 12 months after the inclusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Laboratoire Innotech International

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
ITEC Services

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: David Serfaty, MD, 9 rue Villersexel 75007 PARIS

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 26, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 17, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 17, 2019

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 27, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
March 30, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 5, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 26, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 25, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • PHX 401-14

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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