ContraceptionPhase 4BZK40+NCT03102450
Contraceptive Efficacy, Tolerance and Acceptability of a Benzalkonium Chloride Spermicide Cream In Women Aged Over 40 Years of Age
A Phase 4 study testing Benzalkonium Chloride Spermicide Cream in people with Contraception, run by Laboratoire Innotech International at 15 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 40 years and older, women only
- Conditions the study is for
- Contraception
- What is being tested?
- Benzalkonium Chloride Spermicide Cream
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 15 sitesin 2 countries
- Study dates
- 26 Dec 2017to 17 Oct 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 12Show fewer
- 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
Trial locations and contacts
15 sites in 2 countries.
15 sites in 2 countries
France10 sites
Cabinet Gynecologie
Carnoux-en-Provence, 13470
Cabinet de Gynecologie
Écully, 69130
Cabinet de Gynecologie
Lyon, 69009
Cabinet Gynecologie
Lyon, 69009
Cabinet de Gynecologie
Marseille, 13008
Cabinet de Gynecologie
Nantes, 44000
Cabinet Gynecologie
Neuilly-sur-Seine, 92200
Cabinet Gynecologie
Orléans, 45100
Cabinet Gynecologie
Paris, 75016
Cabinet Gynecologique
Strasbourg, 67000
Russia5 sites
Closed Joint-Stock Company "Heirs"/Nasledniki Ltd.
Moscow, 119192
"The Pirogov Russian National Research Medical University"
Moscow
A.I. Yevdokimov Moscow State University of Medicine and Dentistry"
Moscow
FSBI "Scientific Center of Obstetrics, Gynecology and Perinatology n.a. V.I. Kulakov"
Moscow
I.M. Sechenov First Moscow State Medical University"
Moscow
About this study
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.
Read the 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.
- Conditions
- Contraception
- Being tested
- Benzalkonium Chloride Spermicide Cream
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Benzalkonium Chloride Spermicide CreamDrug
Also called Pharmatex 1,2% vaginal 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)
| Study group | Role | What they receive |
|---|---|---|
| Benzalkonium Chloride Spermicide Cream | Experimental | Pharmatex 1,2% vaginal cream (benzalkonium chloride 1,2g per 100g of vaginal cream) Receives: Drug: Benzalkonium Chloride Spermicide Cream |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: up to 12 months after the inclusion
Secondary outcomes (15)
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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: up to 6 months after the inclusion
Contraceptive Efficacy - Pregnancy rate over up to 12 months - typical use
Contraceptive efficacy of Pharmatex® cream expressed by the rate of pregnancy over up to 12 months of typical use at Visit 4 (M12)
Measured: up to 12 months after the inclusion
Contraceptive Efficacy - Pregnancy rate over up to 12 months - perfect use
Contraceptive efficacy of Pharmatex® cream expressed by the rate of pregnancy over up to 12 months of perfect use at Visit 4 (M12)
Measured: up to 12 months after the inclusion
Number of adverse events
Number of adverse events during the study
Measured: 6 or 12 months after the inclusion
Percentage of adverse events
Percentage of adverse events during the study
Measured: 6 or 12 months after the inclusion
Acceptability - percentage of continuation
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))
Measured: up to 6 or 12 months after the inclusion
Acceptability - adherence
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
Measured: up to 6 or 12 months after the inclusion
Acceptability - ease of use (Likert scale)
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
Measured: up to 6 or 12 months after the inclusion
Acceptability - lubricating effect (Likert scale)
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
Measured: up to 6 or 12 months after the inclusion
Acceptability - global satisfaction of the woman (Likert scale)
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)
Measured: 1, 2, 4, 6, 9, 12 months after the inclusion
Acceptability - global satisfaction of the investigator (Likert scale)
Evaluation of the global satisfaction of the treatment (Likert scale) by the investigator at V2 (M2), V3 (M6) and V4 (M12).
Measured: 2, 6, 12 months after the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2017
- Study start26 Dec 2017
- Primary completion17 Oct 2019
- Study completion17 Oct 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ContraceptionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoire Innotech International
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- ITEC Services
- Responsible party
- Sponsor
- Investigators
- David Serfaty, MD, Principal investigator, 9 rue Villersexel 75007 PARIS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03102450
- Sponsor's protocol ID
- PHX 401-14
- Acronym
- BZK40+
- Status last verified
- Feb 2020
- First submitted
- 27 Mar 2017
- Last updated
- 26 Feb 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contraceptive Efficacy, Tolerance and Acceptability of a Benzalkonium Chloride Spermicide Cream In Women Aged Over 40 Years of Age
- ClinicalTrials.gov ID
- NCT03102450
- Acronym / sponsor ID
- BZK40+ / PHX 401-14
- Conditions
- Contraception
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Laboratoire Innotech InternationalIndustry (pharma, biotech, devices)
- Collaborators
- ITEC Services
- Study start
- 26 Dec 2017 (actual)
- Primary completion
- 17 Oct 2019 (actual)
- Study completion
- 17 Oct 2019 (actual)
- First posted
- 5 Apr 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Benzalkonium Chloride Spermicide Cream | Experimental | Drug: Benzalkonium Chloride Spermicide CreamPharmatex 1,2% vaginal cream (benzalkonium chloride 1,2g per 100g of vaginal cream) |
Who may qualify
- Ages
- 40 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (12 listed)
- 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.)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Benzalkonium Chloride Spermicide CreamAlso: Pharmatex 1,2% vaginal creamOne 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) | Drug | Benzalkonium Chloride Spermicide Cream |
Primary outcome
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)
15 secondary outcomes
Contraceptive Efficacy - PI over up to 12 months - perfect use
Time frame: 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 - PI over up to 6 months - perfect use
Time frame: 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 - Pregnancy rate over up to 6 months - perfect use
Time frame: 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 - Pregnancy rate over up to 12 months - perfect use
Time frame: up to 12 months after the inclusion
Number of adverse events
Time frame: 6 or 12 months after the inclusion
Percentage of adverse events
Time frame: 6 or 12 months after the inclusion
Acceptability - percentage of continuation
Time frame: up to 6 or 12 months after the inclusion
Acceptability - adherence
Time frame: 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
Acceptability - lubricating effect (Likert scale)
Time frame: 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
Acceptability - global satisfaction of the investigator (Likert scale)
Time frame: 2, 6, 12 months after the inclusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Feb 2020.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
David Serfaty, MD principal investigator
9 rue Villersexel 75007 PARIS
15 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Benzalkonium Chloride Spermicide Cream in people with Contraception, run by Laboratoire Innotech International at 15 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 26 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 15 sites in France, Russia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Contraceptive Efficacy- PI over up to 12 months - typical use (time frame: up to 12 months after the inclusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Feb 2020.