Is Cerazette Use Before Nexplanon Insertion Predictive for Bleeding Pattern?

The recruitment status of this study is unknown because the information has not been verified recently.
Verified September 2011 by VL-Medi Oy.
Recruitment status was  Not yet recruiting
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
VL-Medi Oy
ClinicalTrials.gov Identifier:
NCT01438736
First received: September 20, 2011
Last updated: September 21, 2011
Last verified: September 2011
  Purpose

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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by VL-Medi Oy:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • The number of bleeding episodes according to WHO definitions [ Time Frame: 9 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: September 2011
Estimated Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01438736

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

Locations
Finland
VL Medi Oy Not yet recruiting
Helsinki, Finland, 00101
Principal Investigator: Dan Apter, docent         
Sponsors and Collaborators
VL-Medi Oy
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Dan Apter, Docent VL-Medi Oy
  More Information

No publications provided

Responsible Party: VL-Medi Oy
ClinicalTrials.gov Identifier: NCT01438736     History of Changes
Other Study ID Numbers: EudraCT 2011-001492-39, IIPS#39689
Study First Received: September 20, 2011
Last Updated: September 21, 2011
Health Authority: Finland: HUS Ethics Committee
Finland: Finnish Medicines Agency FIMEA

Keywords provided by VL-Medi Oy:
Focus:
preceding
desogestrel predicts
pattern of following
etonogestrel implant

Additional relevant MeSH terms:
Hemorrhage
Pathologic Processes
3-keto-desogestrel
Desogestrel
Contraceptive Agents, Female
Contraceptive Agents
Reproductive Control Agents
Physiological Effects of Drugs
Pharmacologic Actions
Therapeutic Uses
Contraceptives, Oral, Synthetic
Contraceptives, Oral
Progestins
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on August 19, 2014