# CCTN - A MULTI-CENTER, RANDOMIZED STUDY TO EVALUATE THE PHARMACOKINETIC AND PHARMACODYNAMIC PROFILE, CONTRACEPTIVE EFFICACY AND SAFETY OF DAILY ORAL ULIPRISTAL ACETATE

> **NIH NIH N01** · UNIVERSITY OF PENNSYLVANIA · 2020 · $200,402

## Abstract

The Eunice Kennedy Shriver National Institute of Child Health and Human Development
(NICHD) has a mission to develop safe and effective contraceptives for women, including obese
women. Obesity is the number one public health issue facing the US population and is an
independent risk for venous thromboembolism (VTE). Therefore, there is a public health need to
develop effective contraception for woman that does not increase the risk of VTE. One Food and
Drug Administration (FDA)-approved contraceptive method is the progestin-only pill (POP).
This method requires strict adherence to taking the POP at the same time every day. The method
is associated with irregular bleeding which often leads to discontinuation of the method. Daily
low dose oral progesterone receptor modulators (PR.WlS) , such as UPA, have been shown to
inhibit ovulation and cause amenorrhea. The endogenous estrogen level is not affected by the
PRM. Thus, the method will provide a regimen that is easier to follow than a POP regimen and
have a theoretically lower risk of VTE, especially for obese women. In addition, there is in vitro
evidence that UP A may have protective activity against breast cancer. In order to provide
preliminary evidence that daily, low dose UP A could be effective for contraception, a clinical
trial will be conducted in the NICHD Contraceptive Clinical Trials Network (CCTN). The
proposed study will be evaluated sequentially. Initially, women of reproductive age, with normal
menstrual cycles, will receive treatment for 12 weeks (three 28-day cycles) in order to evaluate
the mechanisms of contraceptive efficacy, safety and acceptability of this new contraceptive.
Subjects will be randomized into 3 arms:

• Group 1: UP A 5 mg taken orally daily for 24 days followed by a pill-free interval of 4
days, repeated 3 times.
• Group 2: UP A 10 mg taken orally daily for 84 days (12 weeks) without interruption.
• Group 3: UPA 5 mg taken orally daily for 84 days (12 weeks) without interruption.

## Key facts

- **NIH application ID:** 10079010
- **Project number:** 275201300020I-P00006-27500002-1
- **Recipient organization:** UNIVERSITY OF PENNSYLVANIA
- **Principal Investigator:** KURT BARNHART
- **Activity code:** N01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $200,402
- **Award type:** —
- **Project period:** 2013-07-16 → 2021-12-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10079010

## Citation

> US National Institutes of Health, RePORTER application 10079010, CCTN - A MULTI-CENTER, RANDOMIZED STUDY TO EVALUATE THE PHARMACOKINETIC AND PHARMACODYNAMIC PROFILE, CONTRACEPTIVE EFFICACY AND SAFETY OF DAILY ORAL ULIPRISTAL ACETATE (275201300020I-P00006-27500002-1). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10079010. Licensed CC0.

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