Developing a Highly Acceptable Contraceptive Vaginal Ring

New research finds the Population Council’s one-year contraceptive vaginal ring is highly acceptable to women. Researchers developed and tested a framework for assessing women’s satisfaction with contraceptive vaginal rings. In addition to assessing the acceptance of the Council’s ring, the study showed the framework to be an accurate method for assessing women’s satisfaction with contraceptive vaginal rings in general. 

“We are thrilled that women are pleased with our ring. When women are happy with their contraceptive methods, they are more likely to use them correctly and achieve their reproductive goals,” said Ruth Merkatz, Population Council director of clinical development and medical research and lead researcher on the study. “We also wanted to gain a better understanding of what factors make a contraceptive acceptable to women. With this new model, we can continue studying women’s preferences for contraceptive vaginal rings. The model could also be adapted for assessing other forms of contraception. It will help ensure that new contraceptives are designed and introduced in a way that is responsive to women’s health and family planning needs.”

“The Population Council’s contraceptive vaginal ring has the potential to be a game-changer for women in low-resource settings.” —Ruth Merkatz, Population Council director of clinical development and medical research

Developing a Model to Measure Contraceptive Acceptability

A contraceptive is considered to be “acceptable” if users express satisfaction with the method, use it correctly, and continue to use it over time. Through a review of literature on vaginal rings and contraceptive use, as well as discussions with other investigators, Council researchers identified four areas likely to predict user satisfaction. These factors included:

  • ease of use (ease of ring insertion and removal, remembering the regimen of 21 days in/7 days out for using the ring),
  • ring expulsion or feeling the ring while wearing it,
  • effects on sexual activity, frequency, or pleasure for the woman or her partner, and
  • perceived side effects.

The researchers explored these factors with a questionnaire that asked participants to report their level of overall satisfaction and adherence to instructions for use of the ring. The researchers also tracked whether women continued using the ring for a full year. The questionnaire was administered to 1,036 women who were participating in a Phase 3 clinical trial with the ring at 12 sites across Latin America, the US, Europe and Australia between 2006 and 2009.

A Unique Contraceptive Method

The Council’s long-acting reversible contraceptive vaginal ring contains Nestorone® and ethinyl estradiol. Nestorone is a proprietary investigational progestin that has been shown to be highly effective in preventing ovulation. Ethinyl estradiol is an approved, marketed, synthetic version of the female hormone estrogen. The ring can be used for 13 menstrual cycles and inserted and removed by women without the assistance of trained healthcare providers. Additionally, unlike other vaginal rings, it does not need to be refrigerated before dispensing, which could be beneficial in areas with limited access to methods for refrigeration.

“For these reasons, the Council’s contraceptive vaginal ring has the potential to be a game-changer for women in low-resource settings,” said Merkatz.

What Factors Predict User Satisfaction with a Contraceptive Method?

The researchers found that all four areas they identified as potential contributors to user satisfaction (ease of use, side effects, expulsion, effects on sex and intercourse) were significantly associated with contraceptive acceptability (measured by method satisfaction, correct use, and continuation).

Overall satisfaction with the Council’s contraceptive vaginal ring as a method of contraception was reported from 89 percent of study participants. These satisfied users described reasons from each of the four areas as rationale for their reported satisfaction: they found the ring easy to remove, reported few side effects, did not feel the ring while wearing it, and experienced no change in sexual pleasure or frequency. This suggests that all four areas are important for determining user satisfaction.

The study also demonstrated a direct relationship between user satisfaction and correct and continued use of the vaginal ring: satisfied users were twice as likely to use the contraceptive vaginal ring correctly compared to women who reported dissatisfaction, and five times as likely to use the ring for a full year.

Implications for Healthcare Practitioners

The findings of this study, particularly the reasons a minority of women gave for being dissatisfied with the ring, offer guidance to healthcare practitioners who counsel women about their contraceptive options. Researchers suggested that healthcare professionals should consider some of the issues flagged by dissatisfied users and caution potential users in advance to help ease their experience with the method of contraception.

General side effects typically reported by women who use hormonal contraception led to reported dissatisfaction. Healthcare professionals should inform potential users about the possibility of experiencing these common side effects, and should counsel users on their management. Women’s overall satisfaction with a contraceptive is directly related to how easy they find it to use. Practitioners should discuss and practice using the contraceptive vaginal ring with women who choose it so that they can feel confident when they use it on their own. Satisfaction is also directly related to a method’s impact on a woman’s sexual experiences. Practitioners should address potential issues that may arise due to the presence of the ring during sex, including the experiences and opinions of male partners.

Recommendations for Future Research

Further research is needed to broaden the evidence supporting the use of this new model for contraceptive acceptability. For the Council’s contraceptive vaginal ring, the researchers recommend that future studies examine the experiences of male partners and study the acceptability of the ring in other geographic areas. This is particularly important in sub-Saharan Africa where this contraceptive could be particularly useful because women can use it for a year without the intervention of a healthcare provider and because it does not require refrigeration prior to and during use.


Source
Merkatz, Ruth B., Marlena Plagianos, Elena Hoskin, Michael Cooney, Paul C. Hewett, and Barbara S. Mensch. 2014. “Acceptability of the Nestorone®/ethinyl estradiol contraceptive vaginal ring: Development of a model; implications for introduction,” Contraception 90(5): 514–521.

Funding
US Agency for International Development and US National Institutes of Health