Tamoxifen for the Treatment of Unfavorable Bleeding in Contraceptive Implant Users

Menstruation Disturbances Clinical Trial

Official title:

Tamoxifen for the Treatment of Unfavorable Bleeding Patterns in Etonogestrel Contraceptive Implant Users

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02070692
• Other study ID #: SFPRF14-1
• Secondary ID: SFPRF14-1
• Status: Completed
• Phase: Phase 4
• First received: February 21, 2014
• Last updated: March 28, 2016
• Start date: February 2014
• Est. completion date: December 2015

Study information

• Verified date: March 2016
• Source: Oregon Health and Science University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to study whether a drug called tamoxifen can reduce vaginal bleeding in women who are using the Etonogestrel contraceptive implant.

Description:

Nearly all of the 3 million unintended pregnancies in the United States each year result from inconsistent or non-use of contraception. Increasing use of the most effective methods of contraception will reduce unintended pregnancies and their social, medical and economic consequences. The contraceptive etonogestrel implant (ENG implant) is 20 times more effective at pregnancy prevention than oral contraceptive pills, but it has bleeding side effects that make it unappealing for many women. Tamoxifen, a selective estrogen receptor modulator (SERM) used most commonly for adjuvant treatment of breast cancer, has previously been shown to dramatically reduce bleeding in users of an older levonorgestrel-based contraceptive implant (Norplant tm). It has not been studied in newer progestin-based methods such as the ENG implant. If tamoxifen could stop bleeding in users of the ENG implant, it would give patients and physicians a valuable option for management of progestin-induced irregular bleeding. This research project will test the effectiveness of tamoxifen taken on an as-needed basis to treat abnormal bleeding in ENG implant users. If tamoxifen can be established as an effective treatment for frequent or prolonged bleeding, it will increase the acceptability of the ENG implant, increase its use and reduce unintended pregnancies. This is the first project to evaluate tamoxifen for treatment of unfavorable bleeding in users of the ENG contraceptive implant.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: December 2015
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 15 Years to 45 Years

Eligibility

Inclusion Criteria:

• Current user of the etonogestrel implant (Nexplanon, Implanon) for at least one month

• Experiencing bleeding episodes more frequently than every 24 days, or a single episode of bleeding lasting longer than 14 days

• English or Spanish speaking

• Planning to continue implant use for six months

• Access to a cell phone that can accept and send text messages

Exclusion Criteria:

• Postpartum within six months

• Post-abortion within six weeks

• Pregnant

• Breast-feeding

• Undiagnosed abnormal uterine bleeding pre-dating placement of contraceptive implant

• Bleeding dyscrasia

• Anticoagulation use

• Active cervicitis

• Allergy to tamoxifen

• History of venous thromboembolism

• Current or past breast or uterine malignancy

• Use of medication contraindicated with tamoxifen (coumadin, letrozole, bromocriptine, rifampicin, aminoglutethimide, phenobarbital)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Menstruation Disturbances

Intervention

Drug:
• Tamoxifen
7 day course of tamoxifen during an episode of irregular vaginal bleeding
• Placebo
7 day course of placebo during an episode of irregular vaginal bleeding

Locations

Country	Name	City	State
United States	Oregon Health & Science University (OHSU)	Portland	Oregon

Sponsors (2)

Lead Sponsor	Collaborator
Oregon Health and Science University	Society of Family Planning

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bleeding days	The primary objective of this study is to determine whether tamoxifen taken by users of the ENG implant on an as-needed basis for frequent or prolonged bleeding can reduce the number of bleeding days by at least 40% over 180 days, when compared to placebo.	180 days	No
Secondary	Satisfaction	Secondary objective is to determine whether tamoxifen can improve satisfaction with the implant and with bleeding patterns.	180 days	No
Secondary	Ovulation	A third secondary objective is to determine whether taking tamoxifen at this dose compromises ovulation suppression in ENG users. Tamoxifen is known to transiently raise serum estradiol levels, but does not affect gonadotropin release in premenopausal women. Therefore, it is unlikely to interact with the ovulation suppression provided by the implant. However, to further investigate any theoretical interaction between tamoxifen and etonogestrel, urine markers of ovulation will be collected to document ongoing ovulation suppression with intermittent tamoxifen use.	30 days	Yes

External Links

•   OHSU Women's Health clinical trials