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

Status

UNKNOWN

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01438736

Enrollment

Registered

2011-09-22

Start date

2011-09-30

Completion date

Unknown

Last updated

2011-09-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Bleeding

Keywords

Focus:, preceding, desogestrel predicts, pattern of following, etonogestrel implant

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.

Interventions

DRUGDesogestrel 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

DRUGEtonogestrel 68 mg subdermal implant

Etonogestrel 68 mg subdermal implant for 6 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 40 Years

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.

Design outcomes

Primary

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	9 months

Secondary

Measure	Time frame
The number of bleeding episodes according to WHO definitions	9 months

Countries

Finland

Contacts

Primary ContactDan Apter, Docent

dan.apter@vaestoliitto.fi+358405550842

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026