Is Cerazette Use Before Nexplanon Insertion Predictive for Bleeding Pattern?

Study Overview
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Brief Summary
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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.

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

Conditions
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Bleeding

Intervention / Treatment
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* Drug: Desogestrel 75 micrograms POP (Cerazette), Etonogestrel 68 mg implant (Nexplanon)
* Drug: Etonogestrel 68 mg subdermal implant


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Desogestrel, Etonogestrel<br>Arm 1: 75 microgr desogestrel POP (cerazette) daily for 3 months followed by etonogestrel implant (Nexplanon, 68 mg etonogestrel) for following 6 months | Drug: Desogestrel 75 micrograms POP (Cerazette), Etonogestrel 68 mg implant (Nexplanon)<br>* Desogestrel 75 micrograms POP daily for 3 monts, followed by etonogestrel 68 mg subdermal implant for following 6 months<br>|
| Experimental: Etonogestrel<br>Arm 2: Women staring straight with Nexplanon implant for 6 months | Drug: Etonogestrel 68 mg subdermal implant<br>* Etonogestrel 68 mg subdermal implant for 6 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The number of bleeding episodes according to WHO definitions |  | 9 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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pattern of following, Focus:, preceding, desogestrel predicts, etonogestrel implant