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Does Oral Desogestrel Prior to Insertion of the Etonogestrel Subdermal Implant Improve Continuation Rate at One Year?

Can a Three Months Treatment With Oral Desogestrel Prior to Insertion of the Etonogestrel Subdermal Implant Improve Continuation Rate at One Year?

Status
Terminated
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05174195
Enrollment
67
Registered
2021-12-30
Start date
2016-08-15
Completion date
2019-09-30
Last updated
2021-12-30

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

Conditions

Contraception, Progestogen Adverse Reaction

Brief summary

Objective: The etonogestrel subdermal implant (ESI) is an effective and safe method of contraception. Although highly efficient, ESI produces often side effects that reduce its tolerance and acceptance. Daily oral desogestrel (DSG) prior to the insertion of ESI might help reduce its premature discontinuation. Our aim was to evaluate if this pre-treatment increases ESI's tolerance. Methods: Between 15.08.2016 and 30.09.2019, the investigators conducted a randomized prospective study of women aged 18 to 42 years who were interested to use Implanon and were willing to have 90 days of pre-treatment with DSG, in the family planning clinic of the Geneva University Hospitals and the Hospital of Basel. Women were randomized into either the study ESI only group or to the DSG + ESI group. In the DSG + ESI group, patients were given a 3 months' supply of 75µg of DSG before the insertion of the ESI. A 3 months visit was pre-programmed for all participants where the bleeding calendar and the questionnaires were collected. All patients were called over the phone after 12 months post ESI insertion in both groups.

Detailed description

Study and treatment periods 1 year of patient recruitment 15 months of follow up (90 days OD plus 1 year Implant or 1 year Implant) Measurements and Procedures: Assessment of premature ablation (PA) in months 3-12 (ESI only) or 3-15 (OD+ESI). This will require a contact with all patients at 12/15 months to verify if implant is still in place, and if it was removed, why (and possibly to also reassess symptoms). Women with known PA can be exempted from this follow-up. In case of PA, reasons will be explored and questioned. * Assessment of symptoms at 3 months only (bleeding calendar and satisfaction questionnaire, see below) * Assessment of willingness to receive implant at 3 months in OD+ESI group data collection is limited to these items, in order to limit burden on participants, and to focus resources on high quality of data (as opposed to quantity).

Interventions

DRUGDesogestrel 0.075 milligram

Inserted after 3 months use of DESOGESTREL

Inserted immediately

Sponsors

University Hospital, Geneva
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Randomized prospective

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 42 Years
Healthy volunteers
Yes

Inclusion criteria

* Women age of 18 - 42 years * Interested in the use of ESI * Accepting to have 90 days pre-treatment with OD * Signed informed consent

Exclusion criteria

* Pregnancy * Lactation, * vaginal bleeding of unknown origin, * wish to become pregnant, * weight over 80 kg, * history of deep vein thrombosis/Pulmanory embolism, * hypertension, * Diabetes or other metabolic diseases, * coagulation disorders, * severe hepatic disorder, * history of breast/endometrial cancer, * known hypersensitivity to study drug, * current treatment with enzyme inducing drugs (e.g.: phenytoin, carbamazepine, phenobarbital, etc.)

Design outcomes

Primary

MeasureTime frameDescription
Tolerance of Implanonat 1 year after implant insertion (or at ablation)self-reported

Secondary

MeasureTime frameDescription
Discontinuation of implant,at any time after insertion through study completion, an average of 1 yearfrequency of ablation of any cause and due to intolerance * severity of specific symptoms at 1 year (or at ablation) * severity of specific symptoms at 1 year (or at ablation)
specific symptomsat 1 year after implant insertionmeasured by questionnaires on bleeding patterns and satisfaction on a Likert scale

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026