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Is Cerazette Use Before Nexplanon Insertion Predictive for Bleeding Pattern?

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ClinicalTrials.gov Identifier: NCT01438736
Recruitment Status : Unknown
Verified September 2011 by VL-Medi Oy.
Recruitment status was:  Not yet recruiting
First Posted : September 22, 2011
Last Update Posted : September 22, 2011
Merck Sharp & Dohme LLC
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Bleeding Drug: Desogestrel 75 micrograms POP (Cerazette), Etonogestrel 68 mg implant (Nexplanon) Drug: Etonogestrel 68 mg subdermal implant Phase 4

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: A Randomized Study to Evaluate the Predictive Impact of Using Cerazette Progestin Only Pill Before Nexplanon Insertion Regarding Bleeding Pattern
Study Start Date : September 2011
Estimated Primary Completion Date : November 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bleeding

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
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

Experimental: Etonogestrel
Arm 2: Women staring straight with Nexplanon implant for 6 months
Drug: Etonogestrel 68 mg subdermal implant
Etonogestrel 68 mg subdermal implant for 6 months

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. The number of bleeding episodes according to WHO definitions [ Time Frame: 9 months ]

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01438736

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Contact: Dan Apter, Docent +358405550842 dan.apter@vaestoliitto.fi

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VL Medi Oy
Helsinki, Finland, 00101
Principal Investigator: Dan Apter, docent         
Sponsors and Collaborators
VL-Medi Oy
Merck Sharp & Dohme LLC
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Principal Investigator: Dan Apter, Docent VL-Medi Oy
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Responsible Party: VL-Medi Oy
ClinicalTrials.gov Identifier: NCT01438736    
Other Study ID Numbers: EudraCT 2011-001492-39
IIPS#39689 ( Other Grant/Funding Number: Merck )
First Posted: September 22, 2011    Key Record Dates
Last Update Posted: September 22, 2011
Last Verified: September 2011
Keywords provided by VL-Medi Oy:
desogestrel predicts
pattern of following
etonogestrel implant
Additional relevant MeSH terms:
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Pathologic Processes
Contraceptive Agents, Hormonal
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Contraceptive Agents, Female
Contraceptives, Oral, Hormonal
Contraceptives, Oral
Contraceptives, Oral, Synthetic
Hormones, Hormone Substitutes, and Hormone Antagonists