Combined oral contraceptive treatment for bleeding complaints with the etonogestrel contraceptive implant: a randomised controlled trial.

Abstract

OBJECTIVE:

Estimate symptom improvement rate of women with bleeding complaints using the etonogestrel contraceptive implant when started on continuous combined oral contraceptives (COC).

METHODS:

We conducted a double-blinded randomised controlled trial of women reporting troublesome bleeding related to their etonogestrel contraceptive implant and desiring intervention. Participants received continuous COCs or placebo for four weeks to evaluate self-reported bleeding improvement at four weeks. Participants could continue study treatment or prescribed COCs for another eight weeks if desired. We planned to enroll 130 participants between two sites (80% power to detect a 20% effect size at a 0.05 significance level, with 10% loss to follow up).

RESULTS:

We closed the study after enrolling 26 participants due to recruitment futility. All women on COCs and 75% of placebo users reported bleeding improvement at four weeks (p = 0.09), with 92% and 42%, respectively, reporting significant improvement (p = 0.03). The median number of days until bleeding stopped for at least four days in COC and placebo users was 1 day (range 1-9) and 4.5 days (range 1-28), respectively (p = 0.63). Eight (75%) COC and five (42%) placebo users opted to continue study treatment (p = 0.41). Despite bleeding improvement, women who desired implant removal at enrollment were more likely to re-request removal than those who initially considered other interventions (3 of 5 [60%] vs 1 of 17 [6%], p = 0.03).

CONCLUSION:

Although women who have troublesome bleeding while using the contraceptive implant may experience improvement with no treatment over 4 weeks, women using COCs are more likely to report significant improvement. Clinicaltrials.gov registration number: NCT01963403.

• Authors: Melody Y Hou, Colleen McNicholas, Mitchell D Creinin
• Journal: The European journal of contraception & reproductive health care : the official journal of the European Society of Contraception (Eur J Contracept Reprod Health Care) Vol. 21 Issue 5 Pg. 361-6 (Oct 2016) ISSN: 1473-0782 [Electronic] England
• PMID: 27419258 (Publication Type: Journal Article, Multicenter Study, Randomized Controlled Trial)

Chemical References

• Contraceptive Agents, Female
• Contraceptives, Oral, Combined
• Drug Implants
• etonogestrel
• Desogestrel

Topics

• Adolescent
• Adult
• Contraceptive Agents, Female (adverse effects)
• Contraceptives, Oral, Combined (therapeutic use)
• Desogestrel (adverse effects)
• Double-Blind Method
• Drug Implants
• Female
• Humans
• Menorrhagia (chemically induced, drug therapy)
• Metrorrhagia (chemically induced, drug therapy)
• Young Adult