Self-reported problem bleeding on the contraceptive implant Other
Conditions
Interventions
Intervention: desogestrel 75 micrograms, once daily by mouth.
Active comparator: 30 microgram ethinylestradiol and 150 microgram levonorgestrel COCP, 1 tablet daily by mouth (without a hormone-free i
Sponsors
University of Nottingham
Eligibility
Sex/Gender
Female
Age
16 Years to 45 Years
Inclusion criteria
Inclusion criteria: 1. Female, or trans-male and non-binary people with a uterus, ovary/ovaries and vagina not using hormones other than etonogestrel implant 2. 16 – 45 years old 3 Etonogestrel implant user, with current implant in situ for at least 3 but no more than 24 months 4. Self-reported problem bleeding 5. Willing to complete daily bleeding diary for the trial duration 6. Able to provide Informed Consent 7. Sexually transmitted infection screening undertaken and high sensitivity pregnancy test negative at time of recruitment
Exclusion criteria
Exclusion criteria: 1. Current routine use of oral NSAIDs 2. Current use or use within the last 3 months of hormones or medications known to affect menstrual bleeding, including progestogens, estrogens, androgens, tranexamic acid, selective progestogen receptor modulators 3. Current use or use within the last 6 weeks of liver enzyme inducing medicines which induce the cytochrome CYP3A4 4. Postpartum < 6 weeks (UKMEC 3 or 4) 5. Current use or use within the last 6 months of gonadotrophin-releasing hormone analogues 6. Current use or use within the last 9 months of DMPA 7. Surgery to genital tract altering bleeding, including hysterectomy, bilateral-oophorectomy or endometrial ablation 8. Contraindication (UKMEC Category 3 or 4) or allergy to desogestrel or excipients (including soya bean oil) 9. Contraindication (UKMEC Category 3 or 4) or allergy to COCP containing levonorgestrel and ethinylestradiol or excipients 10. Established pathological reasons for abnormal uterine bleeding, including malignancy or endometrial hyperplasia, fibroids, cervical polyps or lesions (seen on speculum examination), endometrial polyp(s), adenomyosis, coagulopathy, ovulation disorder (e.g. polycystic ovary syndrome) 11. Current known sexually transmitted infection (If STI screening comes back positive then the participant will remain in the trial) 12. Currently pregnant (positive urinary pregnancy test) 13. Previous participation in this trial 14. Declines screening for sexually transmitted infection dual nucleic amplification test (NAAT) for Neisseria Gonorrhoeae and Chlamydia Trachomatis at the time of presentation 15. Declines a speculum examination to assess the cervix for abnormality or other cause for problem bleeding at the time of presentation 16. Declines examination of the implant insertion site to ensure palpable and present at the time of presentation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Participant-reported resolution of problem bleeding, with resolution defined as self-reported significant improvement in the bleeding pattern during the 90-day reference period. Improvement in problem bleeding will be measured by participants’ self-determination that their bleeding pattern has improved using a 5-point Likert scale, 90 days after the participants start their study medicine | — |
Secondary
| Measure | Time frame |
|---|---|
| Clinical effectiveness 1. Longest duration of consecutive non-bleeding (no bleeding or spotting) whole days within the 90 days measured using a 5-point Likert scale at Days 30 and 60 2. Total number of non-bleeding, spotting and bleeding days measured using a Daily bleeding diary during the 90-day treatment period 3. Number and duration of bleeding episodes (one or more consecutive days of bleeding, bounded by bleed-free days) measured using a Daily bleeding diary within the 90 days 4. Time to the longest consecutive non-bleeding days measured using a Daily bleeding diary within the 90 days Treatment acceptability and adherence 1. Acceptability of treatment (global and progestogenic side effects) measured using a Participant Questionnaire on days 30, 60 and 90 2. Adherence to treatment measured using a Daily bleeding diary Safety Discontinuation of allocated treatment and of implant measured using participant-reported discontinuation/removal of their implant in a Participant Questionnaire on days 30, 60 and 90 Cost-effectiveness 1. Quality of life (EQ-5D-5L and ICECAP-A) measured using participant-reported EQ-5D-5L and ICECAP-A on days 30, 60 and 90 2. Primary care, sexual health, and secondary care health resource use measured using a Participant Questionnaire on days 30, 60 and 90 3. Personal and out-of-pocket expenses arising from problem bleeding measured using a Participant Questionnaire on days 30, 60 and 90 4. Intention to continue the trial drug at 3 months measured using a Participant Questionnaire on days 30, 60 and 90 | — |
Countries
England, Scotland, United Kingdom, Wales
Contacts
Public ContactJo Brooks
Outcome results
None listed