Keep Contraceptive Arm Long Acting-iMplant (CALM) and Carry On

Contraception Clinical Trial

— CALM  

Official title:

Keep Contraceptive Arm Long Acting-iMplant (CALM) and Carry On

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04725643
• Other study ID #: 201908
• Status: Active, not recruiting
• Start date: February 17, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: January 2024
• Source: University of California, San Diego
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The investigators will conduct an observational study comparing the number of bleeding days before and after contraceptive implant (Nexplanon) replacement.

Description:

There is very limited information regarding number of bleeding days after replacement of the contraceptive implants (Nexplanon). More detailed information on this topic will help clinicians counsel patients and help women decide if they would like to pursue contraceptive implant replacement.

The investigators will conduct a prospective cohort study of (N=114) among women replacing their contraceptive implant. The primary outcome of the study is the difference in number of bleeding days between the 4-week periods before and after implant replacement. Secondary outcomes include satisfaction with bleeding. Additionally, a secondary outcome will be the number of bleeding days in month 2 and month 3 after replacement of the contraceptive implant. The outcomes will be measured in bleeding diaries and satisfaction surveys.

Through a text messaging application, the investigators will send the participants hyperlinks to the diaries/surveys at the stated time points. Participants will report if they had bleeding and the amount based on the Pictorial Blood Assessment Chart (Higham). Participants will complete weekly surveys regarding their satisfaction with their bleeding utilizing a Likert scale. The investigators will also ask participants to complete a survey regarding their satisfaction with their bleeding at end of month 2 and at the end of month 3 after replacement of their contraceptive implant.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 55
• Est. completion date: December 31, 2024
• Est. primary completion date: January 11, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Reproductive aged women 18-50 years old

• With a contraceptive implant (for patient participants)

• Able to consent in English

• Palpable contraceptive implant

Exclusion Criteria:

• Non-palpable contraceptive implant

Related Conditions & MeSH terms

• Contraception
• Contraceptive Usage
• Family Planning

Intervention

Device:
• Track bleeding patterns before and after implant
Participants will report if they had bleeding and the amount based on the Pictorial Blood Assessment Chart. Participants will also complete weekly surveys regarding their satisfaction with their bleeding. We will also ask participants to complete a survey regarding their satisfaction with their bleeding at end of month 2 and at the end of month 3 after replacement of their contraceptive implant.

Locations

Country	Name	City	State
United States	University of California, San Diego	La Jolla	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Diego	Merck Sharp & Dohme LLC

Country where clinical trial is conducted

United States, 

References & Publications (1)

Higham JM, O'Brien PM, Shaw RW. Assessment of menstrual blood loss using a pictorial chart. Br J Obstet Gynaecol. 1990 Aug;97(8):734-9. doi: 10.1111/j.1471-0528.1990.tb16249.x. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of bleeding days during 4 weeks before replacement	Number of days participants experienced bleeding during the 4 weeks before implant replacement.	4 weeks (28 days) before day of implant replacement.
Primary	Number of bleeding days 4 weeks after replacement	Number of days participants experienced bleeding during the 4 weeks after implant replacement.	4 weeks (28 days) after day of implant replacement
Secondary	Satisfaction with bleeding before replacement	Using a 1-5 Likert scale with 1=Not Satisfied and 5=Very Satisfied, participants will report satisfaction with their bleeding before implant replacement.	4 weeks (28 days) before day of implant replacement
Secondary	Satisfaction with bleeding after replacement	Using a 1-5 Likert scale with 1=Not Satisfied and 5=Very Satisfied, participants will report satisfaction with their bleeding after replacement	4 weeks (28 days) after day of implant replacement
Secondary	Number of bleeding days during the second month after implant replacement	Number of days participants experienced bleeding during the second month after implant replacement	Second month (defined as 29-56 days) after implant replacement
Secondary	Number of bleeding days during the third month post replacement	Number of days participants experienced bleeding during the third month after implant replacement	Third month (defined as 57-84 days) after implant replacement