Trial | NCT01438736  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Unknown status

  • Intervention/Treatment

    desogestrel ...

  • Study Participants

    90
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 Started
Sep 30
2011
Primary Completion
Nov 30
2012
Anticipated
Last Update
Sep 22
2011
Estimate

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

Drug Etonogestrel 68 mg subdermal implant

Etonogestrel 68 mg subdermal implant for 6 months

Desogestrel, Etonogestrel Experimental

Arm 1: 75 microgr desogestrel POP (cerazette) daily for 3 months followed by etonogestrel implant (Nexplanon, 68 mg etonogestrel) for following 6 months

Etonogestrel Experimental

Arm 2: Women staring straight with Nexplanon implant for 6 months

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.
No Results Posted