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

NCT05174195 | Terminated

• 1 other identifier: CCER 16-972
• Study Type: interventional
• Target: 67
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Contraception; Progestogen Adverse Reaction

Outcome Measures

Primary Outcomes (1)

• Tolerance of Implanon

  self-reported

  at 1 year after implant insertion (or at ablation)

Secondary Outcomes (2)

• Discontinuation of implant,

  at any time after insertion through study completion, an average of 1 year

• specific symptoms

  at 1 year after implant insertion

Study Arms (2)

ESI (Implanon NXT® subdermal implant)

ACTIVE COMPARATOR

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

Drug: Implanon NXT® subdermal implant

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

EXPERIMENTAL

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.

Drug: Desogestrel 0.075 milligram; Drug: Implanon NXT® subdermal implant

Interventions

Desogestrel 0.075 milligram DRUG

Inserted after 3 months use of DESOGESTREL

Also known as: Implanon NXT® subdermal implant

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

Implanon NXT® subdermal implant DRUG

Inserted immediately

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

Eligibility Criteria

• Age: 18 Years - 42 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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.)

Sponsors & Collaborators

• University Hospital, Geneva: lead

Related Publications (1)

• 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.

  PMID: 36915205 DERIVED

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Head of Unit Ambulatory Gynecology

Model Details: Randomized prospective

Study Record Dates

• First Submitted: July 29, 2021
• First Posted: December 30, 2021
• Study Start: August 15, 2016
• Primary Completion: March 1, 2018
• Study Completion: September 30, 2019
• Last Updated: December 30, 2021

Record last verified: 2021-12