Is Cerazette Use Before Nexplanon Insertion Predictive for Bleeding Pattern?

VL-Medi Oy

Status and phase: Unknown; Phase 4

Conditions: Bleeding

Treatments: Drug: Desogestrel 75 micrograms POP (Cerazette), Etonogestrel 68 mg implant (Nexplanon); Drug: Etonogestrel 68 mg subdermal implant

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01438736

IIPS#39689 (Other Grant/Funding Number)

EudraCT 2011-001492-39

Details and patient eligibility

About

The purpose of the study is to examine how well three months preceding use of Cerazette progestin only pill predicts the bleeding pattern during following Nexplanon implant use.

Enrollment: 90 estimated patients

Sex: Female

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• Healthy women, 18-40 years of age
• regular menstrual cycle (period 23-35 days)

Exclusion criteria

• -Immediate previous use of progestin only contraception within 2 months
• Known or suspected pregnancy
• Acute tromboembolic disorder
• Presence or history of hepatic disease, as long as the liver function values have not returned to normal
• Undiagnosed vaginal bleeding
• Known or suspected sex-steroid influenced malignancies (e.g. breast cancer)
• Hypersensitivity to the active substances or to any of the excipients of the medicines
• Pregnant or breast feeding within 6 weeks
• The use of other medicinal products that might interact with contraceptive steroids and affect the efficacy of contraceptives and/or might may lead to bleeding irregularities (especially medicines that induce the liver enzyme systems such as cytochrome P450). Examples of active substances are: phenytoin, phenobarbital, primidone, bosentan, carbamatzepine, rifampicin and medicinal products or herbal preparations containing ST.John's wort and to a lesser extend oxcarbazepine, topiramate, felbamate and griseofulvin.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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90 participants in 2 patient groups

Desogestrel, Etonogestrel

Experimental group

Description:

Arm 1: 75 microgr desogestrel POP (cerazette) daily for 3 months followed by etonogestrel implant (Nexplanon, 68 mg etonogestrel) for following 6 months

Treatment:

Drug: Desogestrel 75 micrograms POP (Cerazette), Etonogestrel 68 mg implant (Nexplanon)

Etonogestrel

Experimental group

Description:

Arm 2: Women staring straight with Nexplanon implant for 6 months

Treatment:

Drug: Etonogestrel 68 mg subdermal implant