Health TrialsbyHealthPanel

A Study to Evaluate the Efficacy and Safety of Subcutaneous Levonorgestrel Butanoate for Female Contraception

ConditionsHealthy WomenFemale Contraception
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexFemale
Age18-35
SponsorPremier Research

About this trial

This is a multicenter, open-label, Phase 2b study to evaluate the efficacy and safety of 2 LB SQ injections administered at a 4-month (approximately 17 weeks) interval for female contraception.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

Participant understands and signs an ICF approved by the institutional review board prior to any screening activities.

Female and 18 to 35 years of age, inclusive, at enrollment (Visit 2, Day 1).

Good general overall health with no chronic medical conditions that result in periodic exacerbations requiring significant medical care.

Menstrual cycles of 21 to 35 days in length with typical variation in cycle length of 5 days or less when not using hormonal contraception.

Disqualifiers

Planning pregnancy during study participation through the End -of -Treatment Visit (Visit 11, Day 240).

Is post-partum and has not had 2 spontaneous menses (1 cycle) since delivery or 1 menses since first or second trimester abortion or miscarriage.

Breastfeeding or within 30 days of discontinuing breastfeeding unless the participant has already had 2 menses (1 cycle) following discontinuation of breastfeeding.

Undiagnosed abnormal genital bleeding.

Trial design

Design model

Single group

Treatments tested in this trial

  • Levonorgestrel butanoate

    Drug

    60 mg SQ (70 mg/mL)

Treatment groups

165 Participants
are divided into 1 treatment group
Group A: LB 60 mg SQ (70 mg/mL)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

To evaluate the contraceptive efficacy of 2 LB SQ injections administered at a 4-month (approximately 17 weeks)interval over 8 cycles

As measured by The cumulative pregnancy percentage (calculated using Kaplan-Meier) through 8 cycles

Time frame
224 days

Secondary outcomes

1

To assess the safety of 2 LB SQ injections

To assess the safety of 2 LB SQ injections as measured by: Number of participants with abnormal laboratory values and/or adverse events that are related to treatment

Time frame
240 days
2

To further explore the contraceptive efficacy of 2 LB SQ injections

To further explore the contraceptive efficacy of 2 LB SQ injections as measured by the Pearl Index through 8 cycles

Time frame
224 days
3

To explore bleeding patterns in participants receiving 2 LB SQ injections

To explore bleeding patterns in participants receiving 2 LB SQ injections as measured by Number of bleeding and spotting days per 30-, 90-, and 120-day intervals

Time frame
240 days
4

To evaluate acceptability of 2 LB SQ injections

To evaluate acceptability of 2 LB SQ injections as measured by the number and percentage of subjects that provide each response to a given question related to acceptability on the CCN021b Acceptability and Satisfaction Questionnaire responses at 8 months. Questions range from 'Definitely No' to 'Definitely Yes'.

Time frame
240 days

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Premier Research

Lead sponsor

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: