Is Cerazette Use Before Nexplanon Insertion Predictive for Bleeding Pattern?

September 21, 2011 updated by: VL-Medi Oy

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

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.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

90

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

      • Helsinki, Finland, 00101
        • VL Medi Oy
        • Principal Investigator:
          • Dan Apter, docent

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: 9 months
9 months

Secondary Outcome Measures

Outcome Measure
Time Frame
The number of bleeding episodes according to WHO definitions
Time Frame: 9 months
9 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Collaborators

Investigators

  • Principal Investigator: Dan Apter, Docent, VL-Medi Oy

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2011

Primary Completion (Anticipated)

November 1, 2012

Study Registration Dates

First Submitted

September 20, 2011

First Submitted That Met QC Criteria

September 21, 2011

First Posted (Estimate)

September 22, 2011

Study Record Updates

Last Update Posted (Estimate)

September 22, 2011

Last Update Submitted That Met QC Criteria

September 21, 2011

Last Verified

September 1, 2011

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Bleeding

Clinical Trials on Desogestrel 75 micrograms POP (Cerazette), Etonogestrel 68 mg implant (Nexplanon)

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