A Clinical Trial to Evaluate the Safety and Efficacy of DR-2041(Synthetic Conjugated Estrogens, A) for Treatment of Vulvovaginal Atrophy

Browse trials for

• Atrophy 828

Keywords

• vaginal atrophy
• vaginal dryness
• vaginal itching
• vaginal pain

Atrophy

828 studies on the registry are indexed under Atrophy; 122 are open to participants now.

This study's enrollment of 622 is above the median of 34 across 603 interventional studies indexed under Atrophy.

Lead sponsor

Duramed Research is the lead sponsor of 24 studies on the registry; none are open to participants now.

Study arms

• Experimental
  1

  Drug: DR-2041a

• Experimental
  2

  Drug: DR-2041b

• Placebo comparator
  3

  Other: Placebo

• Placebo comparator
  4

  Other: Placebo

Interventions

• DrugDR-2041a

  1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter

  Also known as: Synthetic conjugated estrogens, A

• DrugDR-2041b

  2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter

  Also known as: Synthetic conjugated estrogens, A

• OtherPlacebo

  1 gram administered vaginally daily for the 1st 7 days then twice a week thereafter

• OtherPlacebo

  2 grams administered vaginally daily for the 1st 7 days then twice a week thereafter

Primary outcomes

1. Mean Change in the Symptom Identified by the Patient to be Most Bothersome

   Change= Week 12 score - Baseline Score. The most bothersome symptom was derived from the subject self-assessment of vaginal atrophy, which consisted of 5 questions concerning severity of symptoms graded on a scale of 0-3(none, mild, moderate or severe) or 7 for not applicable.

   Time frame: Baseline to Week 12

2. Mean Change in Vaginal pH

   Change= Week 12 vaginal pH - Baseline vaginal pH

   Time frame: Baseline to Week 12

3. Mean Change in Maturation Index

   Change= Week 12 maturation index -baseline maturation index. Matuation index was calculated using the following equation: Maturation Index = (% Parabasal cells \* 0) + (% Intermediate Cells \* 0.5) + (% Superficial Cells \* 1.0)

   Time frame: Baseline to Week 12

Secondary outcomes

1. Safety and Tolerability of DR-2041 (Synthetic Conjugated Estrogens, A)

   Any adverse event reported from the beginning of the 28-day screening through the subject's last report.

   Time frame: Up to Week 12

Baseline characteristics

Publications

• Freedman M, Kaunitz AM, Reape KZ, Hait H, Shu H. Twice-weekly synthetic conjugated estrogens vaginal cream for the treatment of vaginal atrophy. Menopause. 2009 Jul-Aug;16(4):735-41. doi: 10.1097/gme.0b013e318199e734. PubMed 19252451 ↗