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

Contraceptive Efficacy, Tolerance and Acceptability of A Benzalkonium Chloride Spermicide Cream In Women Aged Over 40 Years of Age - PHASE IV, INTERNATIONAL, OPEN-LABEL, MULTICENTRE, PROSPECTIVE STUDY - BZK40+

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2016-004188-38-FR

Enrollment

150

Registered

2017-03-28

Start date

2017-12-14

Completion date

Unknown

Last updated

2020-11-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

The current study is conducted in adult women over 40 years of age who need a contraceptive method and who accept to use a spermicide, according to the following inclusion/exclusion criteria and after the signature of the informed consent form. Only outpatients (women) are included in the study. MedDRA version: 19.1 Level: PT Classification code 10067045 Term: Chemical contraception System Organ Class: 10042613 - Surgical and medical procedures

Interventions

Trade Name: Pharmatex® 1.2% vaginal cream Pharmaceutical Form: Vaginal cream INN or Proposed INN: BENZALKONIUM CHLORIDE Other descriptive name: BENZALKONIUM CHLORIDE Concentration unit: % (W/W) percen

Eligibility

Sex/Gender

All

Inclusion 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 need a contraceptive method and who accept to use a spermicide for at least 6 months 3. 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)) 4. Women who accept to comply with the requirements of the protocol including visits assessments and diary completion after each sexual intercourse 5. Women who have had a normal smear test =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
Main Objective: The primary objective of this study is to evaluate the contraceptive efficacy of a benzalkonium chloride spermicide (Pharmatex® cream) expressed by the Pearl Index (PI) over up to 12 months of typical use in women over 40 years of age (the Pearl Index is defined as the number of unintended pregnancies per 100 woman-years of a contraceptive method’s use).;Secondary Objective: The secondary objectives of this study are: - Assessment of the contraceptive efficacy of this benzalkonium chloride spermicide (Pharmatex® cream) expressed by the Pearl Index (PI) over up to 12 months of perfect use and over up to 6 months of typical and perfect use, - Assessment of the contraceptive efficacy of this benzalkonium chloride spermicide (Pharmatex® cream) expressed by rate of pregnancy over up to 6 months and over up to 12 months of typical and perfect use, - Assessment of the tolerance of this benzalkonium chloride spermicide (Pharmatex® cream) in women over 40 years of age, - Assessment of the acceptability of this benzalkonium chloride spermicide (Pharmatex® cream) in women over 40 years of age. ;Primary end point(s): EFFICACY 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);Timepoint(s) of evaluation of this end point: Primary end points over up to 12 months	—

Measure

Time frame

Main Objective: The primary objective of this study is to evaluate the contraceptive efficacy of a benzalkonium chloride spermicide (Pharmatex® cream) expressed by the Pearl Index (PI) over up to 12 months of typical use in women over 40 years of age (the Pearl Index is defined as the number of unintended pregnancies per 100 woman-years of a contraceptive method’s use).;Secondary Objective: The secondary objectives of this study are: - Assessment of the contraceptive efficacy of this benzalkonium chloride spermicide (Pharmatex® cream) expressed by the Pearl Index (PI) over up to 12 months of perfect use and over up to 6 months of typical and perfect use, - Assessment of the contraceptive efficacy of this benzalkonium chloride spermicide (Pharmatex® cream) expressed by rate of pregnancy over up to 6 months and over up to 12 months of typical and perfect use, - Assessment of the tolerance of this benzalkonium chloride spermicide (Pharmatex® cream) in women over 40 years of age, - Assessment of the acceptability of this benzalkonium chloride spermicide (Pharmatex® cream) in women over 40 years of age. ;Primary end point(s): EFFICACY 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);Timepoint(s) of evaluation of this end point: Primary end points over up to 12 months

—

Secondary

Measure	Time frame
Secondary end point(s): Efficacy Endpoints 1. Contraceptive efficacy of Pharmatex® cream expressed by the Pearl Index (PI) over up to 12 months of perfect use 2. Contraceptive efficacy of Pharmatex® cream expressed by the Pearl Index (PI) at Visit 3 (M6) over up to 6 months of typical use 3. Contraceptive efficacy of Pharmatex® cream expressed by the Pearl Index (PI) at Visit 3 (M6) over up to 6 months of perfect use 4. Contraceptive efficacy of Pharmatex® cream expressed by the rate of pregnancy over up to 6 months of typical use at Visit 3 (M6) 5. Contraceptive efficacy of Pharmatex® cream expressed by the rate of pregnancy over up to 6 months of perfect use at Visit 3 (M6) 6. Contraceptive efficacy of Pharmatex® cream expressed by the rate of pregnancy over up to 12 months of typical use at Visit 4 (M12) 7. Contraceptive efficacy of Pharmatex® cream expressed by the rate of pregnancy over up to 12 months of perfect use at Visit 4 (M12) Tolerance Endpoints 1. Number and percentage of adverse events during the study and causal role of study treatment Acceptability Endpoints 1. 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)) 2. 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 3. 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 4. Evaluation of the acceptability of the treatment through the lubricating effect at the end of study visit: V3 (M6), or V4 (M12) or at intermediate visit in case of early withdrawal 5. Evaluation of the global satisfaction of the treatment by the woman at V2 (M2), V3 (M6) and V4 (M12)	—

Measure

Time frame

Secondary end point(s): Efficacy Endpoints 1. Contraceptive efficacy of Pharmatex® cream expressed by the Pearl Index (PI) over up to 12 months of perfect use 2. Contraceptive efficacy of Pharmatex® cream expressed by the Pearl Index (PI) at Visit 3 (M6) over up to 6 months of typical use 3. Contraceptive efficacy of Pharmatex® cream expressed by the Pearl Index (PI) at Visit 3 (M6) over up to 6 months of perfect use 4. Contraceptive efficacy of Pharmatex® cream expressed by the rate of pregnancy over up to 6 months of typical use at Visit 3 (M6) 5. Contraceptive efficacy of Pharmatex® cream expressed by the rate of pregnancy over up to 6 months of perfect use at Visit 3 (M6) 6. Contraceptive efficacy of Pharmatex® cream expressed by the rate of pregnancy over up to 12 months of typical use at Visit 4 (M12) 7. Contraceptive efficacy of Pharmatex® cream expressed by the rate of pregnancy over up to 12 months of perfect use at Visit 4 (M12) Tolerance Endpoints 1. Number and percentage of adverse events during the study and causal role of study treatment Acceptability Endpoints 1. 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)) 2. 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 3. 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 4. Evaluation of the acceptability of the treatment through the lubricating effect at the end of study visit: V3 (M6), or V4 (M12) or at intermediate visit in case of early withdrawal 5. Evaluation of the global satisfaction of the treatment by the woman at V2 (M2), V3 (M6) and V4 (M12)

—

Countries

France, Russian Federation

Contacts

Public ContactMedical Affairs Department

LABORATOIRE INNOTECH INTERNATIONAL

bzk40@innothera.com33146151883

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026