Tamoxifen Versus Estradiol for Unscheduled Bleeding in Etonogestrel Implant Users, a Randomized Pilot Trial
Study Details
Study Description
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.
Condition or Disease | Intervention/Treatment | Phase |
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Phase 4 |
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.
Study Design
Arms and Interventions
Arm | Intervention/Treatment |
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Active Comparator: Tamoxifen tamoxifen 10mg daily for 7 days |
Drug: Tamoxifen Citrate 10Mg Tab
nonsteroidal antiestrogen for oral administration in 10 mg tablets. Each tablet contains 15.2 mg of tamoxifen citrate which is equivalent to 10 mg of tamoxifen.
Other Names:
|
Active Comparator: Estradiol estradiol 1mg daily for 7 days |
Drug: Estradiol
estradiol tablets for oral administration contains 1 mg of micronized estradiol per tablet.
Other Names:
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Placebo Comparator: placebo placebo daily for 7 days |
Drug: Placebo
A sugar tablet that does not contain any active medicine
Other Names:
|
Outcome Measures
Primary Outcome Measures
- Duration of bleeding free days [Up to 28 days]
Number of days of no spotting or bleeding after initiation of first treatment until day of subsequent bleeding
Secondary Outcome Measures
- Total number of bleeding free days [Up to 24 weeks]
Total number of no spotting or bleeding days
- Days to first re-treatment [Up to 24 weeks]
Number of days between first and second use of medication
- Total number of re-treatments [Up to 24 weeks]
Total number of times participant used treatment medication
- Satisfaction with bleeding [Up to 24 weeks]
Average satisfaction with bleeding will be assess using daily text surveys. Participants will rate degree of satisfaction with bleeding with the use of symbols (emojis): 1) completely unsatisfied, 2) somewhat unsatisfied, 3) neutral, 4) somewhat satisfied, 5) completely satisfied.
- Affects on daily life activities [Up to 24 weeks]
The average affect of bleeding on daily life activities will be assess using daily text surveys. Participants will rate the degree of affects of bleeding on daily life with the use of a visual analogue scale from 0 (no affects) to 100 (highest possible affects)
Eligibility Criteria
Criteria
Inclusion Criteria:
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etonogestrel implant users
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at time of and/or within 21 days of initial use of etonogestrel implant placement
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must agree not to take additional hormonal therapy during the study trial period
Exclusion Criteria:
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within 6 months following vaginal or cesarean delivery
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within 6 weeks following abortion
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currently breastfeeding
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positive pregnancy test
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contraindications to tamoxifen or estrogen
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history of thromboembolism
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undiagnosed abnormal uterine bleeding
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active cervicitis
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bleeding disorder
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use of anticoagulation medications
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an unwillingness or inability to keep a daily menstrual diary or to follow the study criteria
Contacts and Locations
Locations
Site | City | State | Country | Postal Code | |
---|---|---|---|---|---|
1 | Shanthi Ramesh | Richmond | Virginia | United States | 23221 |
2 | Virginia Commonwealth University | Richmond | Virginia | United States | 23298 |
Sponsors and Collaborators
- Virginia Commonwealth University
Investigators
- Principal Investigator: Frances Casey, MD, MPH, VCU Health System
Study Documents (Full-Text)
None provided.More Information
Publications
- Abdel-Aleem H, d'Arcangues C, Vogelsong KM, Gaffield ML, Gülmezoglu AM. Treatment of vaginal bleeding irregularities induced by progestin only contraceptives. Cochrane Database Syst Rev. 2013 Oct 21;(10):CD003449. doi: 10.1002/14651858.CD003449.pub5. Review.
- Abdel-Aleem H, Shaaban OM, Amin AF, Abdel-Aleem AM. Tamoxifen treatment of bleeding irregularities associated with Norplant use. Contraception. 2005 Dec;72(6):432-7. Epub 2005 Aug 9.
- 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.
- Archer DF, Philput CA, Weber ME. Management of irregular uterine bleeding and spotting associated with Norplant. Hum Reprod. 1996 Oct;11 Suppl 2:24-30.
- 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. Erratum in: J Clin Oncol 1994 Jun;12(6):1337.
- DeCensi A, Puntoni M, Guerrieri-Gonzaga A, Caviglia S, Avino F, Cortesi L, Taverniti C, Pacquola MG, Falcini F, Gulisano M, Digennaro M, Cariello A, Cagossi K, Pinotti G, Lazzeroni M, Serrano D, Branchi D, Campora S, Petrera M, Buttiron Webber T, Boni L, Bonanni B. Randomized Placebo Controlled Trial of Low-Dose Tamoxifen to Prevent Local and Contralateral Recurrence in Breast Intraepithelial Neoplasia. J Clin Oncol. 2019 Jul 1;37(19):1629-1637. doi: 10.1200/JCO.18.01779. Epub 2019 Apr 11.
- 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.
- 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.
- 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.
- 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.
- Thomas AM, Hickey M, Fraser IS. Disturbances of endometrial bleeding with hormone replacement therapy. Hum Reprod. 2000 Aug;15 Suppl 3:7-17. Review.
- HM20021901