Clinical trial NCT04933240: Tamoxifen Versus Estradiol for Unscheduled Bleeding in Etonogestrel Implant Users, a Randomized Pilot Trial
Official title: Tamoxifen Versus Estradiol in the Prevention of Unscheduled Bleeding in Etonogestrel Implant Users, a Randomized Controlled Pilot Trial
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE4
Conditions: Vaginal Bleeding
Lead sponsor: Virginia Commonwealth University
Sponsor class: OTHER
First posted: 2021-06-21
Enrollment: 0
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: The purpose of this research study is to evaluate the ability of medicines called tamoxifen or estradiol to prevent annoying vaginal bleeding for arm implant users.

Detailed description: This pilot study compares the use of tamoxifen to estradiol to placebo for seven days once a month up to 5 months in contraceptive implant users starting from the time of implant initiation. Participants will record bleeding and satisfaction response in a daily text diary.

Eligibility criteria: Inclusion Criteria:

* etonogestrel implant users
* at time of and/or within 21 days of initial use of etonogestrel implant placement
* must agree not to take additional hormonal therapy during the study trial period

Exclusion Criteria:

* within 6 months following vaginal or cesarean delivery
* within 6 weeks following abortion
* currently breastfeeding
* positive pregnancy test
* contraindications to tamoxifen or estrogen
* history of thromboembolism
* undiagnosed abnormal uterine bleeding
* active cervicitis
* bleeding disorder
* use of anticoagulation medications
* an unwillingness or inability to keep a daily menstrual diary or to follow the study criteria

Primary outcomes:
measure: Duration of bleeding free days
timeFrame: Up to 28 days
Secondary outcomes:
measure: Total number of bleeding free days
timeFrame: Up to 24 weeks
measure: Days to first re-treatment
timeFrame: Up to 24 weeks
measure: Total number of re-treatments
timeFrame: Up to 24 weeks
measure: Satisfaction with bleeding
timeFrame: Up to 24 weeks
measure: Affects on daily life activities
timeFrame: Up to 24 weeks
Other outcomes:
Locations:
city: Richmond
country: United States
facility: Shanthi Ramesh
state: Virginia
city: Richmond
country: United States
facility: Virginia Commonwealth University
state: Virginia
Study officials:
affiliation: VCU Health System
name: Frances Casey, MD, MPH
role: PRINCIPAL_INVESTIGATOR
References:
citation: Mansour D, Fraser IS, Edelman A, Vieira CS, Kaunitz AM, Korver T, Pong A, Lin J, Shah AK, Fox M, Rekers H, Creinin MD. Can initial vaginal bleeding patterns in etonogestrel implant users predict subsequent bleeding in the first 2 years of use? Contraception. 2019 Oct;100(4):264-268. doi: 10.1016/j.contraception.2019.05.017. Epub 2019 Jun 6.
citation: Edelman AB, Kaneshiro B, Simmons KB, Hauschildt JL, Bond K, Boniface ER, Jensen JT. Treatment of Unfavorable Bleeding Patterns in Contraceptive Implant Users: A Randomized Controlled Trial. Obstet Gynecol. 2020 Aug;136(2):323-332. doi: 10.1097/AOG.0000000000003896.
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citation: Buzdar AU, Hortobagyi GN, Frye D, Ho D, Booser DJ, Valero V, Holmes FA, Birmingham BK, Bui K, Yeh C, et al. Bioequivalence of 20-mg once-daily tamoxifen relative to 10-mg twice-daily tamoxifen regimens for breast cancer. J Clin Oncol. 1994 Jan;12(1):50-4. doi: 10.1200/JCO.1994.12.1.50.
citation: Macpherson AM, Archer DF, Leslie S, Charnock-Jones DS, Makkink WK, Smith SK. The effect of etonogestrel on VEGF, oestrogen and progesterone receptor immunoreactivity and endothelial cell number in human endometrium. Hum Reprod. 1999 Dec;14(12):3080-7. doi: 10.1093/humrep/14.12.3080.
citation: Leslie KK, Walter SA, Torkko K, Stephens JK, Thompson C, Singh M. Effect of tamoxifen on endometrial histology, hormone receptors, and cervical cytology: a prospective study with follow-up. Appl Immunohistochem Mol Morphol. 2007 Sep;15(3):284-93. doi: 10.1097/01.pai.0000213147.54901.12.
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citation: Thomas AM, Hickey M, Fraser IS. Disturbances of endometrial bleeding with hormone replacement therapy. Hum Reprod. 2000 Aug;15 Suppl 3:7-17. doi: 10.1093/humrep/15.suppl_3.7.
citation: Alvarez-Sanchez F, Brache V, Thevenin F, Cochon L, Faundes A. Hormonal treatment for bleeding irregularities in Norplant implant users. Am J Obstet Gynecol. 1996 Mar;174(3):919-22. doi: 10.1016/s0002-9378(96)70326-5.