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

NCT03102450 | Completed Phase 4

• 1 other identifier: PHX 401-14
• Study Type: interventional
• Target: 151
• Locations: 2 countries
• Sites: 15

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.

Conditions

Contraception

Outcome Measures

Primary Outcomes (1)

• 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)

  up to 12 months after the inclusion

Secondary Outcomes (15)

• Contraceptive Efficacy - PI over up to 12 months - perfect use

  up to 12 months after the inclusion

• Contraceptive Efficacy - PI over up to 6 months - typical use

  up to 6 months after the inclusion

• Contraceptive Efficacy - PI over up to 6 months - perfect use

  up to 6 months after the inclusion

• Contraceptive Efficacy - Pregnancy rate over up to 6 months - typical use

  up to 6 months after the inclusion

• Contraceptive Efficacy - Pregnancy rate over up to 6 months - perfect use

  up to 6 months after the inclusion

Study Arms (1)

Benzalkonium Chloride Spermicide Cream

EXPERIMENTAL

Pharmatex 1,2% vaginal cream (benzalkonium chloride 1,2g per 100g of vaginal cream)

Drug: Benzalkonium Chloride Spermicide Cream

Interventions

Benzalkonium Chloride Spermicide Cream DRUG

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)

Also known as: Pharmatex 1,2% vaginal cream

Benzalkonium Chloride Spermicide Cream

Eligibility Criteria

• Age: 40 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 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

You may not qualify if:

• 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)
• 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 deprived of liberty by a legal or administrative decision

Sponsors & Collaborators

• Laboratoire Innotech International: lead
• ITEC Services: collaborator

Study Sites (15)

Cabinet Gynecologie

Carnoux-en-Provence, 13470, France

Location

Cabinet de Gynecologie

Écully, 69130, France

Location

Cabinet de Gynecologie

Lyon, 69009, France

Location

Cabinet Gynecologie

Lyon, 69009, France

Location

Cabinet de Gynecologie

Marseille, 13008, France

Location

Cabinet de Gynecologie

Nantes, 44000, France

Location

Cabinet Gynecologie

Neuilly-sur-Seine, 92200, France

Location

Cabinet Gynecologie

Orléans, 45100, France

Location

Cabinet Gynecologie

Paris, 75016, France

Location

Cabinet Gynecologique

Strasbourg, 67000, France

Location

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

Moscow, 119192, Russia

Location

"The Pirogov Russian National Research Medical University"

Moscow, Russia

Location

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

Moscow, Russia

Location

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

Moscow, Russia

Location

I.M. Sechenov First Moscow State Medical University"

Moscow, Russia

Location

Study Officials

• David Serfaty, MD

  9 rue Villersexel 75007 PARIS

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 27, 2017
• First Posted: April 5, 2017
• Study Start: December 26, 2017
• Primary Completion: October 17, 2019
• Study Completion: October 17, 2019
• Last Updated: February 26, 2020

Record last verified: 2020-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (10); RU (5)