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

NCT ID: NCT05174195

Last Updated: 2021-12-30

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 67 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-08-15
• Study Completion Date: 2019-09-30

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).

Conditions

Contraception; Progestogen Adverse Reaction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

ESI (Implanon NXT® subdermal implant)

In this group, the implant was inserted immediately after thorough explanations of the potential side effects and possible adverse events

Group Type: ACTIVE_COMPARATOR

Implanon NXT® subdermal implant

Intervention Type: DRUG

Inserted immediately

DSG + ESI(Desogestrel +Implanon NXT® subdermal implant)

In this group, patients were given a 3 months' supply of 75µg of DSG to be started immediately after which insertion of an ESI was proposed. Similarly, explanations of the potential side effects and possible adverse events were presented to the patient before treatment initiation.

Group Type: EXPERIMENTAL

Desogestrel 0.075 milligram

Intervention Type: DRUG

Inserted after 3 months use of DESOGESTREL

Implanon NXT® subdermal implant

Intervention Type: DRUG

Inserted immediately

Interventions

Desogestrel 0.075 milligram

Inserted after 3 months use of DESOGESTREL

Intervention Type: DRUG

Implanon NXT® subdermal implant

Inserted immediately

Intervention Type: DRUG

Other Intervention Names

Implanon NXT® subdermal implant

Eligibility Criteria

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.)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 42 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital, Geneva

OTHER

Sponsor Role: lead

Responsible Party

Michal Yaron

Head of Unit Ambulatory Gynecology

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

Lombardi Fah V, Catarino R, Castillo S, Badda M, Gezer-Dickschat S, Thieringer F, Tschudin S, Viviano M, Yaron M. Can a 3 months treatment with oral Desogestrel prior to insertion of the etonogestrel-releasing contraceptive implant improve continuation rate at 1 year? A randomized trial. BMC Res Notes. 2023 Mar 13;16(1):35. doi: 10.1186/s13104-023-06304-3.

Reference Type: DERIVED

PMID: 36915205 (View on PubMed)

Other Identifiers

CCER 16-972

Identifier Type: -

Identifier Source: org_study_id