Is Cerazette Use Before Nexplanon Insertion Predictive for Bleeding Pattern?

Bleeding Clinical Trial

Official title:

A Randomized Study to Evaluate the Predictive Impact of Using Cerazette Progestin Only Pill Before Nexplanon Insertion Regarding Bleeding Pattern

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT01438736
• Other study ID #: EudraCT 2011-001492-39
• Secondary ID: IIPS#39689
• Status: Not yet recruiting
• Phase: Phase 4
• First received: September 20, 2011
• Last updated: September 21, 2011
• Start date: September 2011

Study information

• Verified date: September 2011
• Source: VL-Medi Oy
• Contact: Dan Apter, Docent
• Phone: +358405550842
• Email: dan.apter[@]vaestoliitto.fi
• Is FDA regulated: No
• Health authority: Finland: HUS Ethics CommitteeFinland: Finnish Medicines Agency FIMEA
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 90
• Est. primary completion date: November 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Bleeding
• Hemorrhage

Intervention

Drug:
• Desogestrel 75 micrograms POP (Cerazette), Etonogestrel 68 mg implant (Nexplanon)
Desogestrel 75 micrograms POP daily for 3 monts, followed by etonogestrel 68 mg subdermal implant for following 6 months
• Etonogestrel 68 mg subdermal implant
Etonogestrel 68 mg subdermal implant for 6 months

Locations

Country	Name	City	State
Finland	VL Medi Oy	Helsinki

Sponsors (2)

Lead Sponsor	Collaborator
VL-Medi Oy	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The total number of bleeding days per 90 days reference period in women using Cerazette before Nexplanon and in women starting Nexplanon without preceding POP		9 months	No
Secondary	The number of bleeding episodes according to WHO definitions		9 months	No