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

Contraception Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT05174195
• Other study ID #: CCER 16-972
• Status: Terminated
• Phase: N/A
• Start date: August 15, 2016
• Est. completion date: September 30, 2019

Study information

• Verified date: December 2021
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 67
• Est. completion date: September 30, 2019
• Est. primary completion date: March 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 42 Years

Eligibility

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.)

Related Conditions & MeSH terms

• Contraception

Intervention

Drug:
• Desogestrel 0.075 milligram
Inserted after 3 months use of DESOGESTREL
• Implanon NXT® subdermal implant
Inserted immediately

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tolerance of Implanon	self-reported	at 1 year after implant insertion (or at ablation)
Secondary	Discontinuation of implant,	frequency 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)	at any time after insertion through study completion, an average of 1 year
Secondary	specific symptoms	measured by questionnaires on bleeding patterns and satisfaction on a Likert scale	at 1 year after implant insertion