Is Cerazette Use Before Nexplanon Insertion Predictive for Bleeding Pattern?

Phase 4

• Conditions: Bleeding
• Interventions: Drug: Desogestrel 75 micrograms POP (Cerazette), Etonogestrel 68 mg implant (Nexplanon); Drug: Etonogestrel 68 mg subdermal implant

• Registration Number: NCT01438736
• Lead Sponsor: VL-Medi Oy

Brief 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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2011-09
• Study Start: 2011-09
• Study First Submitted: 2011-09-20
• Study First Submitted QC: 2011-09-21
• Last Update Submitted: 2011-09-21
• Study First Posted: 2011-09-22
• Last Update Posted: 2011-09-22
• Primary Completion: 2012-11

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 90

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Desogestrel, Etonogestrel	Desogestrel 75 micrograms POP (Cerazette), Etonogestrel 68 mg implant (Nexplanon)	Arm 1: 75 microgr desogestrel POP (cerazette) daily for 3 months followed by etonogestrel implant (Nexplanon, 68 mg etonogestrel) for following 6 months
Etonogestrel	Etonogestrel 68 mg subdermal implant	Arm 2: Women staring straight with Nexplanon implant for 6 months

Primary Outcome Measures

Name	Time	Method
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

Secondary Outcome Measures

Name	Time	Method
The number of bleeding episodes according to WHO definitions	9 months

Trial Locations

Locations (1)

VL Medi Oy; 🇫🇮 Helsinki, Finland