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A proof-of Concept, Randomized 3-month Study to Evaluate the Effects of Three Contraceptive Intrauterine Systems Delivering Copper and a Daily Dose of 5, 20 or 40 μg of Ulipristal Acetate (UPA)

NCT03230539 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2017-08-15

No results posted yet for this study

Summary

The UPA doses to be tested in this new IUS, 5, 20 or 40 μg per day, are not expected to suppress ovulation, however they should prevent endometrial growth resulting in endometrial atrophy, minimal bleeding, or even amenorrhea. It is anticipated that with low UPA doses, women will continue to ovulate and secrete progesterone (P) during the secretory phase of the menstrual cycle. As a result, PRM associated endometrial changes (PAECs) that have been described in previous UPA studies when ovulation was suppressed and associated with amenorrhea should not occur and endometria should retain normalcy. These expectations are based on our findings from a previous study in which the UPA doses tested were insufficient to block ovulation and participants maintained P secretion with normal endometria (protocol 349). Further evidence regarding the benefit of using low doses of UPA in a copper IUS stems from a small rhesus macaque proof of principle study that included an UPA-IUS delivering 40 or 60 μg/d of UPA, and fixed doses of E2 and cyclic P delivered via implants over 3 cycles.24 Indices of endometrial proliferation were significantly reduced in 3 out of 5 animals in that study; the endometria were atrophied with some glandular cysts, and typical PAECs were limited. Glands were generally small and tubular, however, in some animals they were large and dilated; resembling cysts with minimal evidence of proliferative activity.24 No bleeding was observed in the treated monkeys during progesterone withdrawal over the 3 cycles.

Conditions

  • Contraception

Interventions

DRUG

Ulipristal Acetate IUS delivering Cu and 5μg

This is a proof-of-concept study utilizing a randomized dose-finding, parallel design to assess the effects of an IUS delivering Cu and 5, 20, or 40 μg of UPA over 12 weeks.

DRUG

Ulipristal Acetate IUS delivering Cu and 20μg

This is a proof-of-concept study utilizing a randomized dose-finding, parallel design to assess the effects of an IUS delivering Cu and 5, 20, or 40 μg of UPA over 12 weeks.

DRUG

Ulipristal Acetate IUS delivering Cu and 40μg

This is a proof-of-concept study utilizing a randomized dose-finding, parallel design to assess the effects of an IUS delivering Cu and 5, 20, or 40 μg of UPA over 12 weeks.

Sponsors & Collaborators

  • Population Council

    lead OTHER

Principal Investigators

  • Ruth Merkatz, RN · Population Council

Study Design

Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
38 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2017-05-01
Primary Completion
2018-01-31
Completion
2018-05-31

Countries

  • Dominican Republic

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03230539 on ClinicalTrials.gov