Vaginal Bleeding Clinical Trial
Official title:
Tamoxifen Versus Estradiol in the Prevention of Unscheduled Bleeding in Etonogestrel Implant Users, a Randomized Controlled Pilot Trial
NCT number | NCT04933240 |
Other study ID # | HM20021901 |
Secondary ID | |
Status | Withdrawn |
Phase | Phase 4 |
First received | |
Last updated | |
Start date | May 2022 |
Est. completion date | December 2024 |
Verified date | May 2022 |
Source | Virginia Commonwealth University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | December 2024 |
Est. primary completion date | June 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 15 Years to 45 Years |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
United States | Shanthi Ramesh | Richmond | Virginia |
United States | Virginia Commonwealth University | Richmond | Virginia |
Lead Sponsor | Collaborator |
---|---|
Virginia Commonwealth University |
United States,
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. — View Citation
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. — View 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. — View Citation
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. — View 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. Erratum in: J Clin Oncol 1994 Jun;12(6):1337. — View Citation
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. — View 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. — View 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. — View 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. — View 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. — View Citation
Thomas AM, Hickey M, Fraser IS. Disturbances of endometrial bleeding with hormone replacement therapy. Hum Reprod. 2000 Aug;15 Suppl 3:7-17. Review. — View Citation
* Note: There are 11 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Duration of bleeding free days | Number of days of no spotting or bleeding after initiation of first treatment until day of subsequent bleeding | Up to 28 days | |
Secondary | Total number of bleeding free days | Total number of no spotting or bleeding days | Up to 24 weeks | |
Secondary | Days to first re-treatment | Number of days between first and second use of medication | Up to 24 weeks | |
Secondary | Total number of re-treatments | Total number of times participant used treatment medication | Up to 24 weeks | |
Secondary | Satisfaction with bleeding | 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. | Up to 24 weeks | |
Secondary | Affects on daily life activities | 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) | Up to 24 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT00921778 -
Long-Term Outcome Following Laparoscopic Supracervical Hysterectomy Performed With and Without Excision of the Endocervix in a Reverse Cone Pattern
|
N/A | |
Completed |
NCT02472184 -
Optimal Order of Concurrent Office Hysteroscopy and Endometrial Biopsy
|
N/A | |
Recruiting |
NCT04612881 -
Fitostimoline Vaginal Pessaries in Women With Hysterectomy. Randomized, Perspective, Monoscentric Study.
|
||
Completed |
NCT00339651 -
Preliminary Study of Endometrial Hyperplasia Groundwork for a Study to Define Precursors of Endometrial Cancer
|
||
Completed |
NCT05668806 -
RWE Study in the Treatment of Cervical Lesions of Various Etiology
|
||
Terminated |
NCT04277962 -
Estimating Blood Loss Using TritonTM in Vaginal Deliveries: A Validation Trial
|
N/A | |
Active, not recruiting |
NCT02752282 -
Anticipatory Counseling on LNG-IUS Continuation, Utilization and Satisfaction
|
N/A | |
Completed |
NCT02385747 -
Uterine Cavity Assessment and Endometrial Hormonal Receptors in Women With Peri and Post Menopausal Bleeding
|
N/A | |
Completed |
NCT03856307 -
Reliability of Simple Sonographic Findings Acquired With Hand-held Apparatuses to Inform Obstetric Diagnosis
|
||
Completed |
NCT01868308 -
Screening To Obviate Preterm Birth
|
N/A | |
Completed |
NCT05840471 -
Tranexamic Acid as an Intervention in Abruptio Placenta
|
N/A | |
Not yet recruiting |
NCT05645848 -
The Rate and Predictors of Vaginal Bleeding Among Women With Placenta Previa
|
||
Completed |
NCT05661708 -
Use of Chitosan Powder in Loop Electrosurgical Excision Procedure
|
Phase 4 | |
Completed |
NCT03074903 -
Does Skyla Insertion Timing Impact Bleeding?
|
N/A |