Phase
Condition
Contraception
Treatment
N/AClinical Study ID
Ages > 40 Female
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Women ≥ 40 years of age, fertile, having had at least one menstrual cycle in thecourse of the last three months
Women who were informed about the risks and benefits of all contraceptive methods, andfor 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 testshould be performed at investigator's office then confirmed by a blood test performedin a local laboratory (quantitative beta hCG dosage)).))
Women who accept to comply with the requirements of the protocol including visitsassessments 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
Exclusion
Exclusion Criteria:
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 BaselineVisit
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 andspontaneous 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 participating or having participated in a clinical trial within four weeks priorto inclusion
Women deprived of liberty by a legal or administrative decision
Study Design
Study Description
Connect with a study center
Cabinet Gynecologie
Carnoux-en-Provence, 13470
FranceSite Not Available
Cabinet Gynecologie
Lyon, 69009
FranceSite Not Available
Cabinet de Gynecologie
Lyon, 69009
FranceSite Not Available
Cabinet de Gynecologie
Marseille, 13008
FranceSite Not Available
Cabinet de Gynecologie
Nantes, 44000
FranceSite Not Available
Cabinet Gynecologie
Neuilly-sur-Seine, 92200
FranceSite Not Available
Cabinet Gynecologie
Orléans, 45100
FranceSite Not Available
Cabinet Gynecologie
Paris, 75016
FranceSite Not Available
Cabinet Gynecologique
Strasbourg, 67000
FranceSite Not Available
Cabinet de Gynecologie
Écully, 69130
FranceSite Not Available
"The Pirogov Russian National Research Medical University"
Moscow,
Russian FederationSite Not Available
A.I. Yevdokimov Moscow State University of Medicine and Dentistry"
Moscow,
Russian FederationSite Not Available
Closed Joint-Stock Company "Heirs"/Nasledniki Ltd.
Moscow, 119192
Russian FederationSite Not Available
FSBI "Scientific Center of Obstetrics, Gynecology and Perinatology n.a. V.I. Kulakov"
Moscow,
Russian FederationSite Not Available
I.M. Sechenov First Moscow State Medical University"
Moscow,
Russian FederationSite Not Available

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