Standardized Counseling for Irregular Bleeding in Birth Control Users

Not currently recruiting at 2 trial locations

Overseen By Tenaya Drapkin, MSW

Age: 18 - 65

Sex: Female

Trial Phase: Phase 4

Sponsor: Planned Parenthood of the St. Louis Region and Southwest Missouri

Must be taking: Nexplanon

Disqualifiers: Recent Nexplanon use

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether a standardized counseling script can improve satisfaction for individuals using a birth control implant. The focus is on clearly explaining potential bleeding patterns to help users know what to expect and feel more confident in their choice. Participants will receive either this new counseling approach (Additional Standardized Counseling) or standard counseling. This trial suits those getting a birth control implant for the first time and who speak English. As a Phase 4 trial, the birth control implant is already FDA-approved and proven effective, and this research aims to understand how it benefits more patients.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It focuses on counseling for users of a specific birth control implant.

What is the safety track record for the additional standardized counseling?

Research has shown that standardized counseling helps people understand and manage the side effects of birth control implants more effectively. Although specific safety data about the counseling itself is lacking, studies indicate that it assists users in dealing with irregular bleeding, a common side effect affecting about 10–18% of users. The counseling aims to set clear expectations and improve satisfaction with the treatment. While not a drug or procedure that directly affects the body, the counseling helps users handle potential side effects more effectively. ^{1 2 3 4 5}

Why are researchers enthusiastic about this trial?

Researchers are excited about this trial because it aims to improve how we manage irregular bleeding in birth control users through standardized counseling. Unlike typical approaches that rely on general clinician advice, this trial focuses on providing additional, structured guidance to users. The hope is that this method will offer more consistent support and better outcomes for those experiencing irregular bleeding, potentially setting a new standard for patient care in this area.

What evidence suggests that this trial's counseling methods could be effective for reducing discontinuation rates due to irregular bleeding?

Research has shown that better counseling about unexpected bleeding can increase satisfaction and continued use of birth control methods. In this trial, participants may receive Additional Standardized Counseling, which studies have shown makes individuals 39% more likely to continue using contraception three to six months later compared to those who received regular care. Specifically, those who received more detailed information were more likely to continue using their birth control. By using a set script and visual aids, this approach helps users understand what to expect with bleeding patterns. This improved understanding can lead to greater satisfaction and a lower chance of stopping the method early. ^{1 2 3 6 7}

Who Is on the Research Team?

Colleen P McNicholas, DO, MSCI

Principal Investigator

Planned Parenthood of the St. Louis Region and Southwest Missouri

Are You a Good Fit for This Trial?

This trial is for individuals seeking to use the Nexplanon implant for birth control and can consent in English. It's not open to those who've used Nexplanon within the last 12 weeks.

Inclusion Criteria

I am getting a Nexplanon implant for birth control.

Ability to consent in English

Exclusion Criteria

I have used a Nexplanon implant in the last 12 weeks.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Counseling and Implant Insertion

Participants receive standardized or standard of care counseling and have the contraceptive implant inserted

1 day

1 visit (in-person)

Follow-up

Participants are monitored for satisfaction and discontinuation rates over time

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Additional Standardized Counseling

Trial Overview The study tests whether a standardized counseling script with visuals about expected bleeding patterns from using Nexplanon affects users' satisfaction and reduces early discontinuation of the implant.

How Is the Trial Designed?

Group I: Additional Standardized Counseling Experimental Treatment 1 Intervention

Group II: Standard of Care Clinician Counseling Active Control 1 Intervention

Who Is Running the Clinical Trial?

Planned Parenthood of the St. Louis Region and Southwest Missouri

Lead Sponsor

Trials

3

Recruited

740+

Merck Sharp & Dohme LLC

Industry Sponsor

Trials

4,096

Recruited

5,232,000+

Chirfi Guindo

Merck Sharp & Dohme LLC

Chief Marketing Officer since 2022

Degree in Engineering from Ecole Centrale de Paris, MBA from New York University Stern School of Business

Robert M. Davis

Merck Sharp & Dohme LLC

Chief Executive Officer since 2021

JD from Northwestern University Pritzker School of Law, MBA from Northwestern University Kellogg Graduate School of Management, Bachelor's in Finance from Miami University

Published Research Related to This Trial

About 51% of the 6.6 million pregnancies in the US are unintended, with a significant portion occurring among women not using contraception, highlighting the need for better contraceptive education and access.

Unscheduled bleeding is a major reason women discontinue contraceptive methods, and improving counseling and management of this side effect could enhance satisfaction and continuation rates with contraceptive use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Unscheduled bleeding and contraceptive choice: increasing satisfaction and continuation rates. Villavicencio, J., Allen, RH.[2020]

In a study involving 4317 women aged 18-50 from 24 countries, those taking nomegestrol acetate (NOMAC)/17β-estradiol (E2) experienced significantly higher rates of absent scheduled bleeding compared to those on drospirenone/ethinyl estradiol (DRSP/EE), with rates ranging from 17.6% to 31.6% for NOMAC/E2 versus 3.4% to 5.8% for DRSP/EE.

The study found that factors such as age, body weight, and smoking status were associated with higher rates of absent scheduled bleeding and amenorrhea in women using NOMAC/E2, while unscheduled bleeding was more common in women starting the regimen.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pooled analysis of two randomized, open-label studies comparing the effects of nomegestrol acetate/17β-estradiol and drospirenone/ethinyl estradiol on bleeding patterns in healthy women. Mansour, D., Westhoff, C., Kher, U., et al.[2017]

In a study involving 165 healthy women over 7 cycles, the vaginal contraceptive NuvaRing demonstrated a low incidence of breakthrough bleeding (5.01%) and irregular withdrawal bleeding (1.94%), indicating effective cycle control.

The study reported no pregnancies and minimal adverse effects, with the most common being weight gain and headaches, suggesting that the low hormonal dose and vaginal delivery method may enhance safety and tolerability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An open-label, multicentre trial to evaluate the vaginal bleeding pattern of the combined contraceptive vaginal ring NuvaRing. Bruni, V., Pontello, V., Luisi, S., et al.[2022]

A bleeding-pattern prediction model developed from data of 1351 women using the LNG-IUS 12 was able to classify 70.4% of participants correctly, helping to inform counseling on expected bleeding after IUS placement.

The fixed-cluster model outperformed the regression-tree model in predicting bleeding patterns, providing clearer and more informative results for women using different types of LNG-IUS devices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Predicting menstrual bleeding patterns with levonorgestrel-releasing intrauterine systems. Frenz, AK., Ahlers, C., Beckert, V., et al.[2021]

A panel has proposed new standardized criteria for assessing menstrual bleeding changes associated with contraceptive methods, focusing on three key aspects: pattern, flow, and duration of bleeding.

These recommendations aim to improve the understanding of bleeding outcomes for users and healthcare providers, allowing for better comparisons between contraceptive products and enhancing data synthesis in future studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recommendations for standardization of bleeding data analyses in contraceptive studies. Creinin, MD., Vieira, CS., Westhoff, CL., et al.[2022]

In a 1-year study involving 1864 women, the flexible(MIB) dosing regimen of ethinylestradiol and drospirenone resulted in significantly fewer bleeding or spotting days (40 days) compared to the conventional 24/4 regimen (52 days), improving user satisfaction.

The flexible(MIB) regimen also demonstrated good contraceptive efficacy with a pregnancy rate of 1.65 per 100 woman-years, indicating it is a safe and effective option for managing intracyclic bleeding in extended oral contraceptive use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bleeding profile of a flexible extended regimen of ethinylestradiol/drospirenone in US women: an open-label, three-arm, active-controlled, multicenter study. Jensen, JT., Garie, SG., Trummer, D., et al.[2013]

Starting oral contraceptives (OCs) on the fifth day of menses leads to better compliance and a lower incidence of early breakthrough bleeding compared to starting on the first day of menses, based on a study of 100 healthy women.

The study suggests that initiating OCs on day five may enhance patient adherence to the regimen without affecting other demographic factors like age or parity.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A delayed starting schedule of oral contraception: the effect on the incidence of breakthrough bleeding and compliance in women. Yeshaya, A., Orvieto, R., Kauschansky, A., et al.[2019]

In a study involving 2070 participants over 13 cycles, users of the segesterone acetate and ethinyl estradiol contraceptive vaginal system reported good cycle control, with 98% documenting scheduled bleeding and a low discontinuation rate of only 1.8% due to unacceptable bleeding.

Unscheduled bleeding/spotting was reported by 13.2% to 21.7% of women per cycle, with Black women more likely to experience it compared to White women, indicating a need for further research into demographic factors affecting bleeding patterns.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Bleeding profile associated with 1-year use of the segesterone acetate/ethinyl estradiol contraceptive vaginal system: pooled analysis from Phase 3 trials. Vieira, CS., Fraser, IS., Plagianos, MG., et al.[2020]

Oral hormonal contraceptives have become safer and more convenient over the past 50 years, but there is a rising incidence of unscheduled bleeding and spotting associated with lower steroid doses.

There is a lack of standardized methods for collecting and analyzing data on bleeding and spotting in clinical trials of combined hormonal contraceptives, which complicates the ability of clinicians to inform patients accurately about these side effects.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Combined hormonal contraceptive trials: variable data collection and bleeding assessment methodologies influence study outcomes and physician perception. Mishell, DR., Guillebaud, J., Westhoff, C., et al.[2008]

In a study of 102 adolescent girls with bleeding disorders, nearly half experienced heavy menstrual bleeding at menarche, highlighting the need for awareness and management of menstrual issues in this population.

Hormonal therapy was the most common initial treatment for heavy menstrual bleeding, but over half of the girls did not respond to this treatment, indicating a need for better premenstrual care and alternative treatment strategies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Menstrual Patterns and Treatment of Heavy Menstrual Bleeding in Adolescents with Bleeding Disorders. Dowlut-McElroy, T., Williams, KB., Carpenter, SL., et al.[2018]

Citations

1. withpower.com withpower.com/trial/phase-4-hemorrhage-10-2020-ecc23

Standardized Counseling for Irregular Bleeding in Birth ... Research suggests that improving counseling about unscheduled bleeding can increase satisfaction and continuation rates with contraceptive methods, which ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT04558229

RCT Evaluating Standardized Counseling on Early ... Randomized Control Trial Evaluating Impact of Standardized Counseling on Early Discontinuation for Irregular Bleeding in Users of the Contraceptive Implant.

3. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12535263/

Understanding Problematic Bleeding When Using ... A randomized, controlled trial demonstrated that a 14-day course of COCs in ENG implant users resulted in a higher likelihood of bleeding ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10185303/

Effectiveness and Harms of Contraceptive Counseling and ... A meta-analysis of trials indicated 39% higher contraceptive use 3 to 6 months after interventions compared with usual care or active control (RR, 1.39 [95% CI, ...

5. cosrh.org cosrh.org/Common/Uploaded%20files/documents/ceuguidanceproblematicbleedinghormonalcontraception.pdf

Problematic Bleeding with Hormonal Contraception Advise that 50% of users experience irregular bleeding and suggest stopping c. Suggest waiting a further month and then consider a 30 µg COC d. Switch her ...

6. cdc.gov cdc.gov/mmwr/volumes/73/rr/rr7303a1.htm

U.S. Selected Practice Recommendations for ... This report describes updated recommendations for contraceptive use.

7. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0010782422001524

Recommendations for standardization of bleeding data ... We propose three criteria for assessing bleeding outcomes: pattern, flow, and duration. The descriptors within each criterion depend on whether the ...